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PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease

A Prospective Global Randomized Trial Assessing the Safety and Efficacy of the BuMA Supreme™ Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients With Stable Coronary Artery Disease or Non-ST Segment Elevation Acute Coronary Syndromes

NCT03168776•Sino Medical Sciences Technology Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the XIENCE or Promus durable polymer coronary stents. This prospective, global, multi-center, randomized 2:1, single blind study will enroll up to 1632 subjects at up to 130 investigational sites in North America, Japan, and Europe. Subjects will have clinical follow-up in-hospital and at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient is a male or non-pregnant female ≥20 years of age.
•2. The patient has symptomatic ischemic heart disease, including chronic stable angina (and/or objective evidence of myocardial ischemia on functional study or invasive fractional flow reserve \[FFR\] measurement) or acute coronary syndromes (UA or NSTEMI), that requires elective or urgent percutaneous coronary intervention (PCI).
•3. The patient is an acceptable candidate for percutaneous coronary intervention (PCI) with drug-eluting stents, and for emergent coronary bypass graft (CABG) surgery.
•4. The patient is willing to comply with specified follow-up evaluations.
•5. The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

Exclusion Criteria

•1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
•2. Patients with a history of bleeding diathesis or coagulopathy, contraindications to anti-platelet and/or anticoagulant therapy, or who will refuse transfusion.
•3. Patients who are receiving or will require chronic anticoagulation therapy for any reason.
•4. Known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, ADP receptor antagonists (clopidogrel, prasugrel, ticagrelor, ticlopidine), cobalt chromium, 316L stainless steel or platinum, sirolimus or its analogues, and/or contrast sensitivity that cannot be adequately pre-medicated.
•5. ST-segment elevation myocardial infarction (STEMI) at index presentation or within 7 days prior to randomization.
•6. Known LVEF \<30% or cardiogenic shock requiring pressors or mechanical circulatory assistance (e.g., intra-aortic balloon pump, left ventricular assist device, other temporary cardiac support blood pump).
•7. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation or Cockcroft-Gault formula) or dialysis at the time of screening.
•8. Target vessel percutaneous coronary intervention with stent placement in the previous 3 months.
•9. Planned elective surgery that would require discontinuation of DAPT within 6 months of the index procedure.
•10. Past or pending heart or any other organ transplant, or on the waiting list for any organ transplant.
+3 more criteria

Locations (58)

Cardiology, PC

Birmingham, Alabama, United States

Dignity Health - Mercy Gilbert Medical Center / Chandler Regional Medical Center

Gilbert, Arizona, United States

Smidt Heart Institute Cedars-Sinai Maedical Center

Los Angeles, California, United States

Yale University

New Haven, Connecticut, United States

Medstar Washington HWospital Center

Washington D.C., District of Columbia, United States

Bethesda Hospital East/Daniel Heart and Vascular Center

Boynton Beach, Florida, United States

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

MediQuest Research Group Inc.

Ocala, Florida, United States

Cardiovascular Institute of Northwest Florida

Panama City, Florida, United States

Florida Hospital Tampa

Tampa, Florida, United States

Key Dates

Start Date

October 13, 2017

Primary Completion Date

October 1, 2020

Completion Date

October 1, 2024

Last Updated

January 27, 2026

Enrollment

1,629

ACTUAL participants

Conditions

Coronary Artery Disease

Interventions

BuMA Supreme DES

DEVICE

Xience or Promus DES

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

"Erectile Function After PCI in MI and Non-MI Patients"

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

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