A Prospective Global Randomized Trial Assessing the Safety and Efficacy of the BuMA Supreme™ Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients With Stable Coronary Artery Disease or Non-ST Segment Elevation Acute Coronary Syndromes

Sino Medical Sciences Technology Inc.58 个研究点分布在 5 个国家目标入组 1,629 人2017年10月13日

适应症Coronary Artery Disease

干预措施BuMA Supreme DES Xience or Promus DES

概览

阶段: 不适用
干预措施: BuMA Supreme DES
疾病 / 适应症: Coronary Artery Disease
发起方: Sino Medical Sciences Technology Inc.
入组人数: 1629
试验地点: 58
主要终点: Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements
状态: 已完成
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the XIENCE or Promus durable polymer coronary stents.

This prospective, global, multi-center, randomized 2:1, single blind study will enroll up to 1632 subjects at up to 130 investigational sites in North America, Japan, and Europe. Subjects will have clinical follow-up in-hospital and at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years.

注册库

clinicaltrials.gov

开始日期

2017年10月13日

结束日期

2024年10月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Sino Medical Sciences Technology Inc.

责任方

Sponsor

入排标准

入选标准

•The patient is a male or non-pregnant female ≥20 years of age.
•The patient has symptomatic ischemic heart disease, including chronic stable angina (and/or objective evidence of myocardial ischemia on functional study or invasive fractional flow reserve \[FFR\] measurement) or acute coronary syndromes (UA or NSTEMI), that requires elective or urgent percutaneous coronary intervention (PCI).
•The patient is an acceptable candidate for percutaneous coronary intervention (PCI) with drug-eluting stents, and for emergent coronary bypass graft (CABG) surgery.
•The patient is willing to comply with specified follow-up evaluations.
•The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

排除标准

•Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
•Patients with a history of bleeding diathesis or coagulopathy, contraindications to anti-platelet and/or anticoagulant therapy, or who will refuse transfusion.
•Patients who are receiving or will require chronic anticoagulation therapy for any reason.
•Known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, ADP receptor antagonists (clopidogrel, prasugrel, ticagrelor, ticlopidine), cobalt chromium, 316L stainless steel or platinum, sirolimus or its analogues, and/or contrast sensitivity that cannot be adequately pre-medicated.
•ST-segment elevation myocardial infarction (STEMI) at index presentation or within 7 days prior to randomization.
•Known LVEF \<30% or cardiogenic shock requiring pressors or mechanical circulatory assistance (e.g., intra-aortic balloon pump, left ventricular assist device, other temporary cardiac support blood pump).
•Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation or Cockcroft-Gault formula) or dialysis at the time of screening.
•Target vessel percutaneous coronary intervention with stent placement in the previous 3 months.
•Planned elective surgery that would require discontinuation of DAPT within 6 months of the index procedure.
•Past or pending heart or any other organ transplant, or on the waiting list for any organ transplant.

研究组 & 干预措施

BuMA Supreme Coronary Stent System

干预措施: BuMA Supreme DES

Xience or Promus Everolimus Stent System

干预措施: Xience or Promus DES

结局指标

主要结局

Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements

时间窗: 12 months

TLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR)

次要结局

Number of Participants With Cardiac Death(Assessed at 30 days, 6 months, 12 months, and up to 5 years)
Number of Participants With Major Adverse Cardiac Events (MACE)(Assessed at 30 days, 6 months, 12 months, and up to 5 years)
Number of Participants With Myocardial Infarction (MI)(Assessed at 30 days, 6 months, 12 months, and up to 5 years)
Number of Participants With Stent Thrombosis(Assessed at 30 days, 6 months, 12 months, and up to 5 years)
Number of Participants With Bleeding Complications (BARC Definitions)(Assessed at 30 days, 6 months, 12 months, and up to 5 years)
Lesion Success(Post-Procedure)
Device Success(Post-Procedure)
Procedure Success(Post procedure/Prior to Discharge, an average of 3 days)
Clinically-driven Target Vessel Revascularization (TVR)(Assessed at 30 days, 6 months, 12 months, and up to 5 years)
Target Vessel Failure (TVF)(Assessed at 30 days, 6 months, 12 months, and up to 5 years)