NCT02236975CompletedPhase 2
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.
Sino Medical Sciences Technology Inc.12 sites in 4 countries168 target enrollmentStarted: April 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 168
- Locations
- 12
- Primary Endpoint
- Late Lumen Loss
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
Arms & Interventions
BuMA Supreme Biodegradable drug coating coronary stent system
Experimental
Implant BuMA Supreme stent only
Intervention: BuMA Supreme Biodegradable drug coating coronary stent system (Device)
Resolute Integrity durable polymer stent system
Active Comparator
Implant Resolute stent
Intervention: Resolute Integrity durable polymer stent system (Device)
Outcomes
Primary Outcomes
Late Lumen Loss
Time Frame: Up to 9 month
The primary endpoint is in-stent Late Lumen Loss (LLL) at 9 months after stent implantation as assessed by off-line QCA.
Secondary Outcomes
- Angiographic endpoint(9 and 12 month)
- Clinical endpoint(9 and 12 month)
- Cinical endpoint(9 and 12 month)
Investigators
Study Sites (12)
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