PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: BuMA Supreme DES
* Device: Xience or Promus DES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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. Patients who are receiving immunosuppressant therapy, or who have known immunosuppressive or severe autoimmune disease that will require chronic immunosuppressive therapy. NOTE: Corticosteroid use is permitted. Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound data interpretation, or is associated with a life expectancy of less than 1 year. Current participation in another investigational drug or device study.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BuMA Supreme Coronary Stent System<br> | Device: BuMA Supreme DES<br>* Implant BuMA Supreme stent only<br>|
| Active Comparator: Xience or Promus Everolimus Stent System<br> | Device: Xience or Promus DES<br>* Implant XIENCE family or Promus family only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure (TLF) | defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Safety and Efficacy defined as target lesion failure (TLF) between 12 months and 5 years by landmark analysis | TLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR) | Between 12 months and 5 years | 
| Major adverse cardiac events (MACE) | defined as a composite of all-cause death, myocardial infarction, and target vessel revascularization | 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years | 
| Mortality | classified as cardiac or non-cardiac, and reported cumulatively and individually | 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years | 
| Myocardial infarction (MI) | defined according to the modified Third Universal Definition | 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years | 
| Stent thrombosis | definite or probable (ARC-defined), classified as early, late, or very late | 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years | 
| Bleeding complications (BARC definitions) | evaluated as components and as a composite of BARC Type 3 and 5 bleeding | 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years | 
| Lesion success | defined as attainment of <30% residual stenosis, as measured by quantitative coronary angiography (QCA) using any percutaneous method [evaluated post-procedure] | 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years | 
| Device success | defined as attainment of <30% residual stenosis of the target lesion measured by QCA using the assigned device [evaluated post-procedure] | 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years | 
| Procedure success | defined as lesion success without the occurrence of in-hospital MACE [evaluated in-hospital] | 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years | 
| Clinically-driven target lesion revascularization (TLR) | [evaluated in hospital and at 30 days, 6 months, and 1, 2, 3, 4 and 5 years] | 30 days, 6 months, and 1, 2, 3, 4, and 5 years | 
| Clinically-driven target vessel revascularization (TVR) | [evaluated in hospital and at 30 days, 6 months, and 1, 2, 3, 4 and 5 years] | 30 days, 6 months, and 1, 2, 3, 4, and 5 years | 
| Target vessel failure (TVF) | defined as cardiac death, target vessel-related MI, or clinically-driven target vessel revascularization [evaluated in hospital and at 30 days, 6 months, and 1, 2, 3, 4 and 5 years] | 30 days, 6 months, and 1, 2, 3, 4, and 5 years | 
| Target Lesion Failure (TLF) | defined as cardiac death, target vessel-related MI, or clinically-driven target lesion revascularization [evaluated in hospital and at 30 days, 6 months, and 2, 3, 4 and 5 years] | 30 days, 6 months, and 2, 3, 4, and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting stent