Characteristics of the international clinical studies using objective performance criteria_Chinese Journal of Evidence-Based Medicine

Authors：

YU Mingkun ¹ , MING Yang ² , XIA Ruyu ¹ , WANG Di ¹ , HU Ruixue ¹ , LI Xun ¹ , CHAI Qianyun ³ , ZHANG Ying ¹ , JIANG Zhonghui ⁴ , YU He ² , LIU Jianping ¹ ,  FEI Yutong ¹

1. Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, P.R.China;
2. School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, P.R.China;
3. Journal of Traditional Chinese Medicine, Beijing, 100700, P.R.China;
4. Department of Cardiovascular, Xiyuan Hospital of Beijing University of Chinese Medicine, Beijing, 100091, P.R.China;

Corresponding author：

FEI Yutong, Email: yutong_fei@163.com

Keywords：

Objective performance criteria; Performance goal; Clinical study; Real-world; Effectiveness; Safety

DOI：

10.7507/1672-2531.201905115

Video：

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Objectives To explore the characteristics of the international clinical studies using objective performance criteria (OPC) and provide a reference to design clinical trials and determine external controls.Methods PubMed, The Cochrane Library and EMbase databases were searched for all clinical studies which used OPC. Two reviewers independently screened literature, extracted data and descriptive analysis was then performed.Results A total of 51 English language articles were included. Merely one was published in 2001, and others were published between 2010 and 2018. Twenty-seven articles (27/51, 52.9%) were published between 2017 and 2018, with accumulated impact factors of 411. In the article referring to the reasons for using the objective performance criteria, reasons for using OPC study was primarily the difficulties of randomization and comparison (8/11, 72.7%). Articles with cardiovascular disease and peripheral vascular disease accounted for 86%, and articles on the effectiveness or safety of medical devices accounted for 76.5%. Single-arm trial (40), randomized controlled trials (2), case-control studies (2), case series (5) and diagnostic tests (2) were included. OPCs were mostly derived from the data of clinical trials of other similar products, national standards, specialist association standard and meta-analysis of multiple clinical studies. A total of 27 articles (27/51, 52.9%) used hypothesis testing to compare research results with objective performance goal, and 24 articles (24/51, 47.1%) used the confidence interval method.Conclusions OPC studies are primarily used for safety intervention and effect evaluation. OPC studies are developing very rapidly, especially in the field of cardiovascular studies. Methodological details are reported reasonably sufficient. Reasons for using OPC study are primarily the difficulties of randomization and comparison. Factors such as source of the OPC, sample size, and comparison method should be taken into account. The application of the OPC can not only solve the difficulties of the implementation of numerous clinical research, but also provide new insights for solving the practical difficulties of clinical research in the real-world.

Citation： YU Mingkun, MING Yang, XIA Ruyu, WANG Di, HU Ruixue, LI Xun, CHAI Qianyun, ZHANG Ying, JIANG Zhonghui, YU He, LIU Jianping, FEI Yutong. Characteristics of the international clinical studies using objective performance criteria. Chinese Journal of Evidence-Based Medicine, 2019, 19(11): 1308-1316. doi: 10.7507/1672-2531.201905115 Copy

1.	季聪华, 曹毅, 陈健. 单组试验目标值法在中医临床研究中的应用. 中国中西医结合杂志, 2012, 32(12): 1589-1591.
2.	Food and Drug Administration Center for Devices and Radiological Health. Clinical study designs for catheter ablation devices for treatment of atrial flutter (guidance for industry and FDA staff). Available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM182017.pdf.
3.	李雪迎. 临床验证中的单组目标值法. 中国介入心脏病学杂志, 2015, 23(7): 393.
4.	国家食品药品监督管理局办公室. 持续葡萄糖监测系统注册技术审查指导原则. Available at: http://www.nmpa.gov.cn/directory/web/WS04/images/MjAxOMTqtdo1NrrFzai45ri9vP4uZG9j.doc.
5.	国家食品药品监督管理局办公室. X射线计算机体层摄影设备注册技术审查指导原则. Available at: http://www.sohu.com/a/222181840_694090.
6.	国家食品药品监督管理局办公室. 金属接骨板内固定系统产品注册技术审查指导原则. Available at: https://wenku.baidu.com/view/40a32461f705cc1754270915.html.
7.	Sabik JF 3rd, Rao V, Lange R, et al. One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis. J Thorac Cardiovasc Surg, 2018, 156(4): 1368-1377.
8.	Chan KH, McGrady M, Wilcox I. A leadless intracardiac transcatheter pacing system. N Engl J Med, 2016, 374(26): 2604.
9.	Duray GZ, Ritter P, El-Chami M, et al. Long-term performance of a transcatheter pacing system: 12-month results from the micra transcatheter pacing study. Heart Rhythm, 2017, 14(5): 702-709.
10.	Popma JJ, Adams DH, Reardon MJ, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol, 2014, 63(19): 1972-1981.
11.	Chambers JW, Feldman RL, Himmelstein SI, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv, 2014, 7(5): 510-518.
12.	Kereiakes DJ, Meredith IT, Masotti M, et al. Safety and efficacy of a bioabsorbable polymer-coated, everolimus-eluting coronary stent in patients with diabetes: the EVOLVE II diabetes substudy. EuroIntervention, 2017, 12(16): 1987-1994.
13.	Michael TT, Richardt G, Lansky A, et al. Nine-month results of the BIOHELIX-I clinical trial study: Evaluation of the PRO-Kinetic energy cobalt chromium bare-metal stent system. Catheter Cardiovasc Interv, 2018, 92(6): 1030-1039.
14.	Wang JC, Carrié D, Masotti M, et al. Primary endpoint results of the OMEGA study: one-year clinical outcomes after implantation of a novel platinum chromium bare metal stent. Cardiovasc Revasc Med, 2015, 16(2): 65-69.
15.	Ansel GM, Hopkins LN, Jaff MR, et al. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial. Catheter Cardiovasc Interv, 2010, 76(1): 1-8.
16.	Kandzari DE, Kini AS, Karmpaliotis D, et al. Safety and effectiveness of everolimus-eluting stents in chronic total coronary occlusion revascularization: results from the EXPERT CTO multicenter trial (evaluation of the xience coronary stent, performance, and technique in chronic total occlusions). JACC Cardiovasc Interv, 2015, 8(6): 761-769.
17.	Zaidat OO, Bozorgchami H, Ribó M, et al. Primary results of the multicenter ARISE II study (analysis of revascularization in ischemic stroke with embotrap). Stroke, 2018, 49(5): 1107-1115.
18.	Chinitz LA, Melby DP, Marchlinski FE, et al. Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: results from the SMART SF trial. Europace, 2018, 20(FI_3): f392-f400.
19.	Schwindt AG, Bennett JG Jr, Crowder WH, et al. Lower extremity revascularization using optical coherence tomography-guided directional atherectomy: final results of the evaluation of the pantheris optical coherence tomography imaging atherectomy system for use in the peripheral vasculature (VISION) study. J Endovasc Ther, 2017, 24(3): 355-366.
20.	Carpenter JP, Cuff R, Buckley C, et al. One-year pivotal trial outcomes of the nellix system for endovascular aneurysm sealing. J Vasc Surg, 2017, 65(2): 330-336.
21.	Levie MD, Chudnoff SG. A prospective, multicenter, pivotal trial to evaluate the safety and effectiveness of the AEGEA vapor endometrial ablation system. J Minim Invasive Gynecol, 2019, 26(4): 679-687.
22.	Laura EL, Perkins DVM, Katrin H, et al. The Xience nano^TM everolimus eluting coronary stent system for the treatment of small coronary arteries: The SPIRIT small vessel trial. Catheter Cardiovasc Interv, 2012, 80(4): 546-553.
23.	Hull JE, Jennings WC, Cooper RI, et al. The pivotal multicenter trial of ultrasound-guided percutaneous arteriovenous fistula creation for hemodialysis access. J Vasc Interv Radiol, 2018, 29(2): 149-158.
24.	Laberge P, Garza-Leal J, Fortin C, et al. One-year follow-up results of a multicenter, single-arm, objective performance criteria-controlled international clinical study of the safety and efficacy of the minerva endometrial ablation system. J Minim Invasive Gynecol, 2015, 22(7): 1169-1177.
25.	Price MJ, Saito S, Shlofmitz RA, et al. First report of the resolute onyx 2.0-mm zotarolimus-eluting stent for the treatment of coronary lesions with very small reference vessel diameter. JACC Cardiovasc Interv, 2017, 10(14): 1381-1388.
26.	Teirstein PS, Meredith IT, Feldman RL, et al. Two-year safety and effectiveness of the platinum chromium everolimus-eluting stent for the treatment of small vessels and longer lesions. Catheter Cardiovasc Interv, 2015, 85(2): 207-215.
27.	Saito S, Ando K, Ito Y, et al. Two-year results after coronary stenting of small vessels in Japanese population using 2.25-mm diameter sirolimus-eluting stent with bioresorbable polymer: primary and long-term outcomes of CENTURY JSV study. Cardiovasc Interv Ther, 2019, 34(1): 25-33.
28.	Kandzari DE, Amjadi N, Caputo C, et al. One-year outcomes in "real-world" patients treated with a thin-strut, platinum-chromium, everolimus-eluting stent (from the PROMUS element plus US post-approval study [PE-Plus PAS]). Am J Cardiol, 2016, 117(4): 539-545.
29.	Schreiber TL, Strickman N, Davis T, et al. Carotid artery stenting with emboli protection surveillance study: outcomes at 1 year. J Am Coll Cardiol, 2010, 56(1): 49-57.
30.	Cannon LK, Carey W, Anthony H, et al. Clinical outcomes following implantation of the ION^TM paclitaxel-eluting platinum chromium coronary stent in routine clinical practice: results of the ION US post-approval study. Catheter Cardiovasc Interv, 2018, 86(12): 28044.
31.	Baim DS, Flatley M, Caputo R, et al. Comparison of pre-dilatation vs direct stenting in coronary treatment using the medtronic AVE S670 coronary stent system (the PREDICT trial). Am J Cardiol, 2001, 88(12): 1364-1369.
32.	Cutlip DE, Garratt KN, Novack V, et al. 9-month clinical and angiographic outcomes of the COBRA polyzene-f nanocoated coronary stent system. JACC Cardiovasc Interv, 2017, 10(2): 160-167.
33.	Krajcer Z, Ramaiah VG, Henao EA, et al. Perioperative outcomes from the prospective multicenter least invasive fast-track EVAR (LIFE) registry. J Endovasc Ther, 2018, 25(1): 6-13.
34.	Krajcer Z, Ramaiah V, Huetter M. Fast-track endovascular aneurysm repair: rationale and design of the multicenter Least Invasive Fast-Track EVAR (LIFE) registry. BMC Cardiovasc Disord, 2015, 15: 174.
35.	Scheinert D, Reimers B, Cremonesi A, et al. Independent modular filter for embolic protection in carotid stenting. Circ Cardiovasc Interv, 2017, 10(3): e004244.
36.	Burket MW, Brodmann M, Metzger C, et al. Twelve-month results of the nitinol astron stent in iliac artery lesions. J Vasc Interv Radiol, 2016, 27(11): 1650-1656.
37.	Shammas NW, Pucillo A, Jenkins JS, et al. WIRION embolic protection system in lower extremity arterial interventions: results of the pivotal WISE LE trial. JACC Cardiovasc Interv, 2018, 11(19): 1995-2003.
38.	Clair DG, Adams J, Reen B, et al. The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial. J Endovasc Ther, 2014, 21(2): 213-222.
39.	David SW, Khan ZA, Patel NC, et al. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv, 2019, 93(5): 882-890.
40.	William WN Jr, Feng L, Ferrarotto R, et al. Gefitinib for patients with incurable cutaneous squamous cell carcinoma: a single-arm phase II clinical trial. J Am Acad Dermatol, 2017, 77(6): 1110-1113.
41.	Stavroulakis K, Borowski M, Torsello G, et al. One-year results of first-line treatment strategies in patients with critical limb ischemia (CRITISCH Registry). J Endovasc Ther, 2018, 25(3): 320-329.
42.	Nakamura M, Jaff MR, Settlage RA, et al. Nitinol self-expanding stents for the treatment of obstructive superficial femoral artery disease: three-year results of the reliable Japanese multicenter study. Ann Vasc Dis, 2018, 11(3): 324-334.
43.	Garcia LA, Rosenfield KR, Metzger CD, et al. SUPERB final 3-year outcomes using interwoven nitinol biomimetic supera stent. Catheter Cardiovasc Interv, 2017, 89(7): 1259-1267.
44.	Starling AJ, Tepper SJ, Marmura MJ, et al. A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study). Cephalalgia, 2018, 38(6): 1038-1048.
45.	Christiansen MP, Klaff LJ, Brazg R, et al. A prospective multicenter evaluation of the accuracy of a novel implanted continuous glucose sensor: PRECISE II. Diabetes Technol Ther, 2018, 20(3): 197-206.
46.	Schmidt A, Keirse K, Blessing E, et al. Offroad re-entry catheter system for subintimal recanalization of chronic total occlusions in femoropopliteal arteries: primary safety and effectiveness results of the re-route trial. J Cardiovasc Surg (Torino), 2014, 55(4): 551-558.
47.	Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med, 2018, 379(24): 2307-2318.
48.	Généreux P, Kumsars I, Schneider JE, et al. Dedicated bifurcation stent for the treatment of bifurcation lesions involving large side branches: outcomes from the tryton confirmatory study. JACC Cardiovasc Interv, 2016, 9(13): 1338-1346.
49.	Thomas JL, Ridner M, Cole JH, et al. The clinical evaluation of the CADence device in the acoustic detection of coronary artery disease. Int J Cardiovasc Imaging, 2018, 34(12): 1841-1848.
50.	Xu B, Tu S, Qiao S, et al. Diagnostic accuracy of angiography-based quantitative flow ratio measurements for online assessment of coronary stenosis. J Am Coll Cardiol, 2017, 70(25): 3077-3087.
51.	Gao Z, Zhang R, Xu B, et al. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials. Catheter Cardiovasc Interv, 2015, 85(Suppl 1): 734-743.
52.	Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation, 2013, 128(9): 944-953.
53.	Lee M, Hiremath S, Zambahari R, et al. One-year outcomes of percutaneous coronary intervention with the 38-mm Resolute zotarolimus-eluting stent. Am J Cardiol, 2013, 112(9): 1335-1341.
54.	Soga Y, Takahara M, Iida O, et al. Relationship between primary patency and lesion length following bare nitinol stent placement for femoropopliteal disease. J Endovasc Ther, 2015, 22(6): 862-867.
55.	Iida O, Soga Y, Yamauchi Y, et al. Clinical efficacy of endovascular therapy for patients with critical limb ischemia attributable to pure isolated infrapopliteal lesions. J Vasc Surg, 2013, 57(4): 974-981.
56.	Silber S, Serruys PW, Leon MB, et al. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv, 2013, 6(4): 357-368.
57.	Nakano M, Hirano K, Iida O, et al. Clinical efficacy of infrapopliteal endovascular procedures for hemodialysis patients with critical limb ischemia. Ann Vasc Surg, 2015, 29(6): 1225-1234.
58.	Cox DR. Regression models and life tables (with discussion). J R Stat Soc Series B, 1972, 34: 187-220.
59.	Food and Drug Administration. Replacement heart valve guidance. Washington DC: US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Division of Cardiovascular, Respiratory and Neurological Devices, 1994.
60.	Food and Drug Administration Center for Devices and Radiological Health. Clinical study designs for catheter ablation devices for treatment of atrial flutter. Guidance for Industry and FDA Staff. Available at: http://www.fda.gov/cdrt/ode/guidance/1678.html.
61.	李卫, 赵耐青. 单组目标值临床试验的统计学考虑. 中国卫生统计, 2017, 34(3): 505-508.
62.	陆梦洁, 刘玉秀, 卢光明, 等. 单组目标值临床试验多指标时的样本量估计. 中国临床药理学与治疗学, 2017, 22(8): 917-921.
63.	吕德良, 李雪迎, 朱赛楠, 等. 目标值法在医疗器械非随机对照临床试验中的应用. 中国卫生统计, 2009, 26(3): 258-260, 263.
64.	成琪, 刘玉秀, 陈林, 等. 单组临床试验目标值法的精确样本含量估计及统计推断. 中国临床药理学与治疗学, 2011, 16(5): 517-522.
65.	曾治宇, 林娜. 单样本率比较(单组目标值法)的样本量计算及其简便实现. 中国卫生统计, 2018, 35(2): 313-314.

1. 季聪华, 曹毅, 陈健. 单组试验目标值法在中医临床研究中的应用. 中国中西医结合杂志, 2012, 32(12): 1589-1591.
2. Food and Drug Administration Center for Devices and Radiological Health. Clinical study designs for catheter ablation devices for treatment of atrial flutter (guidance for industry and FDA staff). Available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM182017.pdf.
3. 李雪迎. 临床验证中的单组目标值法. 中国介入心脏病学杂志, 2015, 23(7): 393.
4. 国家食品药品监督管理局办公室. 持续葡萄糖监测系统注册技术审查指导原则. Available at: http://www.nmpa.gov.cn/directory/web/WS04/images/MjAxOMTqtdo1NrrFzai45ri9vP4uZG9j.doc.
5. 国家食品药品监督管理局办公室. X射线计算机体层摄影设备注册技术审查指导原则. Available at: http://www.sohu.com/a/222181840_694090.
6. 国家食品药品监督管理局办公室. 金属接骨板内固定系统产品注册技术审查指导原则. Available at: https://wenku.baidu.com/view/40a32461f705cc1754270915.html.
7. Sabik JF 3rd, Rao V, Lange R, et al. One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis. J Thorac Cardiovasc Surg, 2018, 156(4): 1368-1377.
8. Chan KH, McGrady M, Wilcox I. A leadless intracardiac transcatheter pacing system. N Engl J Med, 2016, 374(26): 2604.
9. Duray GZ, Ritter P, El-Chami M, et al. Long-term performance of a transcatheter pacing system: 12-month results from the micra transcatheter pacing study. Heart Rhythm, 2017, 14(5): 702-709.
10. Popma JJ, Adams DH, Reardon MJ, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol, 2014, 63(19): 1972-1981.
11. Chambers JW, Feldman RL, Himmelstein SI, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv, 2014, 7(5): 510-518.
12. Kereiakes DJ, Meredith IT, Masotti M, et al. Safety and efficacy of a bioabsorbable polymer-coated, everolimus-eluting coronary stent in patients with diabetes: the EVOLVE II diabetes substudy. EuroIntervention, 2017, 12(16): 1987-1994.
13. Michael TT, Richardt G, Lansky A, et al. Nine-month results of the BIOHELIX-I clinical trial study: Evaluation of the PRO-Kinetic energy cobalt chromium bare-metal stent system. Catheter Cardiovasc Interv, 2018, 92(6): 1030-1039.
14. Wang JC, Carrié D, Masotti M, et al. Primary endpoint results of the OMEGA study: one-year clinical outcomes after implantation of a novel platinum chromium bare metal stent. Cardiovasc Revasc Med, 2015, 16(2): 65-69.
15. Ansel GM, Hopkins LN, Jaff MR, et al. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial. Catheter Cardiovasc Interv, 2010, 76(1): 1-8.
16. Kandzari DE, Kini AS, Karmpaliotis D, et al. Safety and effectiveness of everolimus-eluting stents in chronic total coronary occlusion revascularization: results from the EXPERT CTO multicenter trial (evaluation of the xience coronary stent, performance, and technique in chronic total occlusions). JACC Cardiovasc Interv, 2015, 8(6): 761-769.
17. Zaidat OO, Bozorgchami H, Ribó M, et al. Primary results of the multicenter ARISE II study (analysis of revascularization in ischemic stroke with embotrap). Stroke, 2018, 49(5): 1107-1115.
18. Chinitz LA, Melby DP, Marchlinski FE, et al. Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: results from the SMART SF trial. Europace, 2018, 20(FI_3): f392-f400.
19. Schwindt AG, Bennett JG Jr, Crowder WH, et al. Lower extremity revascularization using optical coherence tomography-guided directional atherectomy: final results of the evaluation of the pantheris optical coherence tomography imaging atherectomy system for use in the peripheral vasculature (VISION) study. J Endovasc Ther, 2017, 24(3): 355-366.
20. Carpenter JP, Cuff R, Buckley C, et al. One-year pivotal trial outcomes of the nellix system for endovascular aneurysm sealing. J Vasc Surg, 2017, 65(2): 330-336.
21. Levie MD, Chudnoff SG. A prospective, multicenter, pivotal trial to evaluate the safety and effectiveness of the AEGEA vapor endometrial ablation system. J Minim Invasive Gynecol, 2019, 26(4): 679-687.
22. Laura EL, Perkins DVM, Katrin H, et al. The Xience nano^TM everolimus eluting coronary stent system for the treatment of small coronary arteries: The SPIRIT small vessel trial. Catheter Cardiovasc Interv, 2012, 80(4): 546-553.
23. Hull JE, Jennings WC, Cooper RI, et al. The pivotal multicenter trial of ultrasound-guided percutaneous arteriovenous fistula creation for hemodialysis access. J Vasc Interv Radiol, 2018, 29(2): 149-158.
24. Laberge P, Garza-Leal J, Fortin C, et al. One-year follow-up results of a multicenter, single-arm, objective performance criteria-controlled international clinical study of the safety and efficacy of the minerva endometrial ablation system. J Minim Invasive Gynecol, 2015, 22(7): 1169-1177.
25. Price MJ, Saito S, Shlofmitz RA, et al. First report of the resolute onyx 2.0-mm zotarolimus-eluting stent for the treatment of coronary lesions with very small reference vessel diameter. JACC Cardiovasc Interv, 2017, 10(14): 1381-1388.
26. Teirstein PS, Meredith IT, Feldman RL, et al. Two-year safety and effectiveness of the platinum chromium everolimus-eluting stent for the treatment of small vessels and longer lesions. Catheter Cardiovasc Interv, 2015, 85(2): 207-215.
27. Saito S, Ando K, Ito Y, et al. Two-year results after coronary stenting of small vessels in Japanese population using 2.25-mm diameter sirolimus-eluting stent with bioresorbable polymer: primary and long-term outcomes of CENTURY JSV study. Cardiovasc Interv Ther, 2019, 34(1): 25-33.
28. Kandzari DE, Amjadi N, Caputo C, et al. One-year outcomes in "real-world" patients treated with a thin-strut, platinum-chromium, everolimus-eluting stent (from the PROMUS element plus US post-approval study [PE-Plus PAS]). Am J Cardiol, 2016, 117(4): 539-545.
29. Schreiber TL, Strickman N, Davis T, et al. Carotid artery stenting with emboli protection surveillance study: outcomes at 1 year. J Am Coll Cardiol, 2010, 56(1): 49-57.
30. Cannon LK, Carey W, Anthony H, et al. Clinical outcomes following implantation of the ION^TM paclitaxel-eluting platinum chromium coronary stent in routine clinical practice: results of the ION US post-approval study. Catheter Cardiovasc Interv, 2018, 86(12): 28044.
31. Baim DS, Flatley M, Caputo R, et al. Comparison of pre-dilatation vs direct stenting in coronary treatment using the medtronic AVE S670 coronary stent system (the PREDICT trial). Am J Cardiol, 2001, 88(12): 1364-1369.
32. Cutlip DE, Garratt KN, Novack V, et al. 9-month clinical and angiographic outcomes of the COBRA polyzene-f nanocoated coronary stent system. JACC Cardiovasc Interv, 2017, 10(2): 160-167.
33. Krajcer Z, Ramaiah VG, Henao EA, et al. Perioperative outcomes from the prospective multicenter least invasive fast-track EVAR (LIFE) registry. J Endovasc Ther, 2018, 25(1): 6-13.
34. Krajcer Z, Ramaiah V, Huetter M. Fast-track endovascular aneurysm repair: rationale and design of the multicenter Least Invasive Fast-Track EVAR (LIFE) registry. BMC Cardiovasc Disord, 2015, 15: 174.
35. Scheinert D, Reimers B, Cremonesi A, et al. Independent modular filter for embolic protection in carotid stenting. Circ Cardiovasc Interv, 2017, 10(3): e004244.
36. Burket MW, Brodmann M, Metzger C, et al. Twelve-month results of the nitinol astron stent in iliac artery lesions. J Vasc Interv Radiol, 2016, 27(11): 1650-1656.
37. Shammas NW, Pucillo A, Jenkins JS, et al. WIRION embolic protection system in lower extremity arterial interventions: results of the pivotal WISE LE trial. JACC Cardiovasc Interv, 2018, 11(19): 1995-2003.
38. Clair DG, Adams J, Reen B, et al. The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial. J Endovasc Ther, 2014, 21(2): 213-222.
39. David SW, Khan ZA, Patel NC, et al. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv, 2019, 93(5): 882-890.
40. William WN Jr, Feng L, Ferrarotto R, et al. Gefitinib for patients with incurable cutaneous squamous cell carcinoma: a single-arm phase II clinical trial. J Am Acad Dermatol, 2017, 77(6): 1110-1113.
41. Stavroulakis K, Borowski M, Torsello G, et al. One-year results of first-line treatment strategies in patients with critical limb ischemia (CRITISCH Registry). J Endovasc Ther, 2018, 25(3): 320-329.
42. Nakamura M, Jaff MR, Settlage RA, et al. Nitinol self-expanding stents for the treatment of obstructive superficial femoral artery disease: three-year results of the reliable Japanese multicenter study. Ann Vasc Dis, 2018, 11(3): 324-334.
43. Garcia LA, Rosenfield KR, Metzger CD, et al. SUPERB final 3-year outcomes using interwoven nitinol biomimetic supera stent. Catheter Cardiovasc Interv, 2017, 89(7): 1259-1267.
44. Starling AJ, Tepper SJ, Marmura MJ, et al. A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study). Cephalalgia, 2018, 38(6): 1038-1048.
45. Christiansen MP, Klaff LJ, Brazg R, et al. A prospective multicenter evaluation of the accuracy of a novel implanted continuous glucose sensor: PRECISE II. Diabetes Technol Ther, 2018, 20(3): 197-206.
46. Schmidt A, Keirse K, Blessing E, et al. Offroad re-entry catheter system for subintimal recanalization of chronic total occlusions in femoropopliteal arteries: primary safety and effectiveness results of the re-route trial. J Cardiovasc Surg (Torino), 2014, 55(4): 551-558.
47. Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med, 2018, 379(24): 2307-2318.
48. Généreux P, Kumsars I, Schneider JE, et al. Dedicated bifurcation stent for the treatment of bifurcation lesions involving large side branches: outcomes from the tryton confirmatory study. JACC Cardiovasc Interv, 2016, 9(13): 1338-1346.
49. Thomas JL, Ridner M, Cole JH, et al. The clinical evaluation of the CADence device in the acoustic detection of coronary artery disease. Int J Cardiovasc Imaging, 2018, 34(12): 1841-1848.
50. Xu B, Tu S, Qiao S, et al. Diagnostic accuracy of angiography-based quantitative flow ratio measurements for online assessment of coronary stenosis. J Am Coll Cardiol, 2017, 70(25): 3077-3087.
51. Gao Z, Zhang R, Xu B, et al. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials. Catheter Cardiovasc Interv, 2015, 85(Suppl 1): 734-743.
52. Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation, 2013, 128(9): 944-953.
53. Lee M, Hiremath S, Zambahari R, et al. One-year outcomes of percutaneous coronary intervention with the 38-mm Resolute zotarolimus-eluting stent. Am J Cardiol, 2013, 112(9): 1335-1341.
54. Soga Y, Takahara M, Iida O, et al. Relationship between primary patency and lesion length following bare nitinol stent placement for femoropopliteal disease. J Endovasc Ther, 2015, 22(6): 862-867.
55. Iida O, Soga Y, Yamauchi Y, et al. Clinical efficacy of endovascular therapy for patients with critical limb ischemia attributable to pure isolated infrapopliteal lesions. J Vasc Surg, 2013, 57(4): 974-981.
56. Silber S, Serruys PW, Leon MB, et al. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv, 2013, 6(4): 357-368.
57. Nakano M, Hirano K, Iida O, et al. Clinical efficacy of infrapopliteal endovascular procedures for hemodialysis patients with critical limb ischemia. Ann Vasc Surg, 2015, 29(6): 1225-1234.
58. Cox DR. Regression models and life tables (with discussion). J R Stat Soc Series B, 1972, 34: 187-220.
59. Food and Drug Administration. Replacement heart valve guidance. Washington DC: US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Division of Cardiovascular, Respiratory and Neurological Devices, 1994.
60. Food and Drug Administration Center for Devices and Radiological Health. Clinical study designs for catheter ablation devices for treatment of atrial flutter. Guidance for Industry and FDA Staff. Available at: http://www.fda.gov/cdrt/ode/guidance/1678.html.
61. 李卫, 赵耐青. 单组目标值临床试验的统计学考虑. 中国卫生统计, 2017, 34(3): 505-508.
62. 陆梦洁, 刘玉秀, 卢光明, 等. 单组目标值临床试验多指标时的样本量估计. 中国临床药理学与治疗学, 2017, 22(8): 917-921.
63. 吕德良, 李雪迎, 朱赛楠, 等. 目标值法在医疗器械非随机对照临床试验中的应用. 中国卫生统计, 2009, 26(3): 258-260, 263.
64. 成琪, 刘玉秀, 陈林, 等. 单组临床试验目标值法的精确样本含量估计及统计推断. 中国临床药理学与治疗学, 2011, 16(5): 517-522.
65. 曾治宇, 林娜. 单样本率比较(单组目标值法)的样本量计算及其简便实现. 中国卫生统计, 2018, 35(2): 313-314.

Chinese Journal of Evidence-Based Medicine

Characteristics of the international clinical studies using objective performance criteria

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