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

Sino Medical Sciences Technology

Status and phase

Completed

Phase 3

Phase 2

Conditions

Coronary Artery Disease

Treatments

Device: BuMA Supreme Biodegradable drug coating coronary stent system

Device: Resolute Integrity durable polymer stent system

Study type

Interventional

Funder types

Industry

Identifiers

NCT02236975

PIONEER

Details and patient eligibility

About

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.

Enrollment

168 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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