A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)

Study Overview
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Brief Summary
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PIONEER-II RCT trial is a prospective, multicenter, randomized, non-inferiority registry trial. 539 subjects from about 40 interventional cardiology centers in China will be enrolled to evaluate In-stent late lumen loss(LLL) as the primary endpoint at 9 months. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.

Detailed Description
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Realizing even more uniform and complete endothelial coverage, BuMA Supreme™ biodegradable drug coating coronary stent system comprises a new generation of biodegradable drug eluting stent under development by SINOMED. BuMA Supreme™ reconfigures BuMA™ DES utilizing a high caliber cobalt chromium platform coated with rapidly degrading PLGA scaffold.

Official Title
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A Prospective, Multicenter Trial Program in China to Evaluate the Efficacy and Safety of BuMA Supreme (eG Grafting) Biodegradable Polymer Sirolimus Eluting Stent in Patients With de Novo Coronary Lesions, RCT Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: BuMA Supreme
* Device: BuMA™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75, male or non-pregnant female Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI Target lesion is primary and de-novo coronary artery disease The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated) Lesion diameter stenosis ≥70% (visually estimated) For each target lesion, same stent implantation only Acceptable candidate for coronary artery bypass grafting (CABG) Understand the study purpose, willing to participate and sign the letter of consent, agrees to the follow-up visits including a 9 month angiographic follow-up Exclusion Criteria: Acute MI within 1 week Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion More than 3 stents required Patients refuse to be implanted stent Calcified lesion failed in pre-dilation, twisted lesion and lesion unsuitable for stent delivery and expansion In-stent restenosis Planned percutaneous coronary intervention (PCI) within 3 months post procedure Other stents implanted within 1 year Severe heart failure (NYHA above III) or left ventricle ejection fraction (EF) <40% Renal function damage, blood creatinine > 176.82 μmol/L Bleeding tendency, active peptic ulcer disease, cerebral or subarachnoid hemorrhage, cerebral apoplexy within half year and contraindication for any anti-platelet or anticoagulation agents Allergic to drugs or agents used in stent or protocol (PLGA, sirolimus, aspirin, clopidogrel, contrast agent, cobalt, nickel, chromium, iron, wolfram et. al.) Life expectation < 12 months Have not reached the primary end point when participating in other trial Poor compliance to the protocol Heart implantation cases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 group<br>This group contains 319 subjects. Among them, 220 subjects will be implanted with regular specifications and 99 subjects with narrower, wider or longer ones. | Device: BuMA Supreme<br>* Stent platform: cobalt-chromium alloy<br>|
| Active Comparator: BuMA™ group<br>This group contains 220 subjects. | Device: BuMA™<br>* Stent platform: stainless steel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-stent Late Lumen Loss, 9M | The primary endpoint is in-stent Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA). | QCA at 9-month follow-up window | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent implantation success rate | The stent implantation success rate includes device success, lesion success and clinical success. | 5 years after PCI | 
| Binary restenosis rate | Binary restenosis was defined in every segment (proximal, distal, and stent) as a >50% diameter. | 9 months | 
| in-segment LLL | to evaluate the in-sigment Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA). | 9 months | 
| diameter stenosis degree | to compare the lumen diameter at 9-month after stent implantation with the baseline diameter as assessed by off-line quantitative coronary angiography (QCA). | 9 months | 
| Device-oriented Composite Endpoint (DoCE) | Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven target lesion revascularization (TLR). | 1, 6, 12 month, and annually up to 5 years post procedure | 
| Patient-oriented Composite Endpoint (PoCE) | Patient-oriented Composite Endpoint is defined as all cause death, all myocardial ischemia (MI), or any revascularization. | 1, 6, 12 month, and annually up to 5 years post procedure | 
| Academic Research Consortium(ARC) defined stent thrombosis | Definite and probable stent thrombosis during acute, subacute, later and very late phase. | 5 years after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug eluting stents, Interventional Cardiology