Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments buma supreme biodegradable drug coating coronary stent system, resolute integrity durable polymer stent system
Phase phase 2/phase 3
Sponsor Sino Medical Sciences Technology Inc.
Start date April 2015
End date November 2016
Trial size 168 participants
Trial identifier NCT02236975, PIONEER

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Implant BuMA Supreme stent only
buma supreme biodegradable drug coating coronary stent system
(Active Comparator)
Implant Resolute stent
resolute integrity durable polymer stent system

Primary Outcomes

Measure
Late Lumen Loss
time frame: Up to 9 month

Secondary Outcomes

Measure
Angiographic endpoint
time frame: 9 and 12 month
Angiographic endpoint
time frame: 9 and 12 month
Angiographic endpoint
time frame: 9 and 12 month
Angiographic endpoint
time frame: 9 and 12 month
Clinical endpoint
time frame: 9 and 12 month
Cinical endpoint
time frame: 9 and 12 month
Clinical endpoint
time frame: 9 and 12 month
Clinical endpoint
time frame: 9 and 12 month
Clinical endpoint
time frame: 9 and 12 month

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. The subject is at least 18 years of age. 2. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. 3. 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 4. The patient has a planned intervention of a single de-novo lesion in one or two separate major epicardial territories (LAD, LCX or RCA). 5. Diameter Stenosis≥50 and<100%. 6. 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). 7. The target lesion reference diameter must be visually estimated to be ≥2.5 mm and ≤4.5 mm in diameter. 8. Written informed consent. 9. The patient agrees to the follow-up visits including a 9 month angiographic follow-up. 10. Patient must have completed the follow-up phase of any previous study. Exclusion Criteria: 1. 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. 2. 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 3. Patient suffered from stroke/TIA during the last 6 months. 4. LVEF <30% 5. 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) 6. 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). 7. Patient undergoing planned surgery within 6 months with the necessity to stop DAPT. 8. Patient requiring oral anticoagulation (Coumadin, Novel Oral Anticoagulant (NOAC)) 9. History of bleeding diathesis or coagulopathy 10. The patient is a recipient of a heart transplant 11. Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study, sirolimus, zotarolimus, or cobalt-chromium. 12. 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 13. The patient is simultaneously participating in another investigational device or drug study

Additional Information

Official title 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.
Principal investigator Clemens von.Birgelen, MD,Phd
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Sino Medical Sciences Technology Inc..