First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis

Study Overview
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Brief Summary
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Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, Spain and Portugal. Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at baseline (pre- and post-procedure) and at 9 months follow-up.

Official Title
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Prospective, Multi-center, Randomized First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme eG (Electro Grafting) Based Biodegradable Polymer Sirolimus-eluting Stent and Resolute Integrity Zotarolimus-eluting Durable Polymer Stent in Patients With de Novo Coronary Artery Stenosis.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: BuMA Supreme Biodegradable drug coating coronary stent system
* Device: Resolute Integrity durable polymer stent system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is at least 18 years of age. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia The patient has a planned intervention of a single de-novo lesion in one or two separate major epicardial territories (LAD, LCX or RCA). Diameter Stenosis≥50 and<100%. The visually estimated target lesion must be able to be covered by a single BuMA Supreme stent or a single Resolute Integrity stent (for available sizes refer to tables 1 and 2, page 20 and 21). The target lesion reference diameter must be visually estimated to be ≥2.5 mm and ≤4.5 mm in diameter. Written informed consent. The patient agrees to the follow-up visits including a 9 month angiographic follow-up. Patient must have completed the follow-up phase of any previous study. Exclusion Criteria: Female of child bearing potential (age <50 years and last menstruation within the last 12 months). Subjects with age <50 who underwent tubal ligation, ovariectomy or hysterectomy can be included. Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure Patient suffered from stroke/TIA during the last 6 months. LVEF <30% Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance ≤30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment). Patient undergoing planned surgery within 6 months with the necessity to stop DAPT. Patient requiring oral anticoagulation (Coumadin, Novel Oral Anticoagulant (NOAC)) History of bleeding diathesis or coagulopathy The patient is a recipient of a heart transplant Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study, sirolimus, zotarolimus, or cobalt-chromium. Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy The patient is simultaneously participating in another investigational device or drug study

Ages Eligible for Study
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Minimum Age: 18 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 Biodegradable drug coating coronary stent system<br>Implant BuMA Supreme stent only | Device: BuMA Supreme Biodegradable drug coating coronary stent system<br> <br> |
| Active Comparator: Resolute Integrity durable polymer stent system<br>Implant Resolute stent | Device: Resolute Integrity durable polymer stent system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Lumen Loss | The primary endpoint is in-stent Late Lumen Loss (LLL) at 9 months after stent implantation as assessed by off-line QCA. | Up to 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic endpoint | Acute Lumen Gain (mm); | 9 and 12 month | 
| Angiographic endpoint | MLD (mm) post procedure and at 9 months; | 9 and 12 month | 
| Angiographic endpoint | Diameter Stenosis (%) post procedure and at 9 months; | 9 and 12 month | 
| Angiographic endpoint | Binary Restenosis (DS ≥50%) at 9 months | 9 and 12 month | 
| Clinical endpoint | Acute success (device and procedural success) | 9 and 12 month | 
| Cinical endpoint | Device-oriented Composite Endpoints (DoCE) at 1, 9 and 12 months and its individual components. (Device-oriented Composite Endpoint is defined as Cardiac Death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated Target Lesion Revascularization). | 9 and 12 month | 
| Clinical endpoint | Myocardial infarction (Q-wave, Non q-wave) at all time points. | 9 and 12 month | 
| Clinical endpoint | Any revascularization at all time points. | 9 and 12 month | 
| Clinical endpoint | Stent thrombosis according to the ARC definitions up to 12 months follow-up. | 9 and 12 month |