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

NCT03168776 | Completed Results FDA Device

• 1 other identifier: SIN-US-001
• Study Type: interventional
• Target: 1,629
• Locations: 8 countries
• Sites: 58

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Drug-eluting stent

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements

  TLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR)

  12 months

Secondary Outcomes (10)

• Number of Participants With Cardiac Death

  Assessed at 30 days, 6 months, 12 months, and up to 5 years

• Number of Participants With Major Adverse Cardiac Events (MACE)

  Assessed at 30 days, 6 months, 12 months, and up to 5 years

• Number of Participants With Myocardial Infarction (MI)

  Assessed at 30 days, 6 months, 12 months, and up to 5 years

• Number of Participants With Stent Thrombosis

  Assessed at 30 days, 6 months, 12 months, and up to 5 years

• Number of Participants With Bleeding Complications (BARC Definitions)

  Assessed at 30 days, 6 months, 12 months, and up to 5 years

Study Arms (2)

BuMA Supreme Coronary Stent System

EXPERIMENTAL

Device: BuMA Supreme DES

Xience or Promus Everolimus Stent System

ACTIVE COMPARATOR

Device: Xience or Promus DES

Interventions

BuMA Supreme DES DEVICE

Implant BuMA Supreme stent only

BuMA Supreme Coronary Stent System

Xience or Promus DES DEVICE

Implant XIENCE family or Promus family only

Xience or Promus Everolimus Stent System

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is a male or non-pregnant female ≥20 years of age.
• 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).
• The patient is an acceptable candidate for percutaneous coronary intervention (PCI) with drug-eluting stents, and for emergent coronary bypass graft (CABG) surgery.
• The patient is willing to comply with specified follow-up evaluations.
• 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).

You may not qualify if:

• 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.
• Patients with a history of bleeding diathesis or coagulopathy, contraindications to anti-platelet and/or anticoagulant therapy, or who will refuse transfusion.
• Patients who are receiving or will require chronic anticoagulation therapy for any reason.
• 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.
• ST-segment elevation myocardial infarction (STEMI) at index presentation or within 7 days prior to randomization.
• 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).
• 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.
• Target vessel percutaneous coronary intervention with stent placement in the previous 3 months.
• Planned elective surgery that would require discontinuation of DAPT within 6 months of the index procedure.
• Past or pending heart or any other organ transplant, or on the waiting list for any organ transplant.
• Patients who are receiving immunosuppressant therapy, or who have known immunosuppressive or severe autoimmune disease that will require chronic immunosuppressive therapy. NOTE: Corticosteroid use is permitted.
• Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound data interpretation, or is associated with a life expectancy of less than 1 year.
• Current participation in another investigational drug or device study.

Sponsors & Collaborators

• Sino Medical Sciences Technology Inc.: lead
• Nova Vascular LLC: collaborator

Study Sites (58)

Cardiology, PC

Birmingham, Alabama, 35211, United States

Location

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

Gilbert, Arizona, 85297, United States

Location

Smidt Heart Institute Cedars-Sinai Maedical Center

Los Angeles, California, 90048, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Medstar Washington HWospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Bethesda Hospital East/Daniel Heart and Vascular Center

Boynton Beach, Florida, 33435, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

MediQuest Research Group Inc.

Ocala, Florida, 34471, United States

Location

Cardiovascular Institute of Northwest Florida

Panama City, Florida, 32401, United States

Location

Florida Hospital Tampa

Tampa, Florida, 33613, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

St. Vincent's Medical Group

Indianapolis, Indiana, 46290, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50314, United States

Location

Norton Brownsboro Hospital

Louisville, Kentucky, 40241, United States

Location

Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Northern Michigan Hospital d.b.a. McLaren Northern Michigan

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Essential Health

Duluth, Minnesota, 55805, United States

Location

North MS Medical Center

Tupelo, Mississippi, 38801, United States

Location

CHI Health Research Center

Omaha, Nebraska, 68124, United States

Location

Cardiovascular Associates of Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

Columbia University Medical Center / New York Presbyterian Hospital

New York, New York, 10032, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

North Ohio Heart

Elyria, Ohio, 44035, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Mercy St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Genesis Hospital

Zanesville, Ohio, 43701, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Berks Cardiologists, Ltd.

Wyomissing, Pennsylvania, 19610, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

AnMed Health

Anderson, South Carolina, 29621, United States

Location

Tyler Cardiovascular Consultants

Tyler, Texas, 75701, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Imelda

Bonheiden, 2820, Belgium

Location

CHU Charleroi

Charleroi, Belgium

Location

Ziekenhuis Oost Limburg Genk

Genk, 3600, Belgium

Location

Jessa Hospital

Hasselt, 3500, Belgium

Location

Foothills Medical Centre

Calgary, Alberta, T2N-2T9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B-1W8, Canada

Location

Shonan Kamakura General Hospital

Kanagawa, Kamakura City, 247-8533, Japan

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

MCL

Leeuwarden, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Hospital Ramon y Cajal

Madrid, Spain

Location

Instituto de Investigación Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, 36312, Spain

Location

Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland

Location

University Hospital Geneva HUG, Clinic for Cardiology

Geneva, 1211, Switzerland

Location

St Bartholomew's Hospital

London, United Kingdom

Location

Related Publications (1)

• Lansky AJ, Kereiakes DJ, Baumbach A, Windecker S, Hussain Y, Pietras C, Dressler O, Issever O, Curtis M, Bertolet B, Zidar JP, Smits PC, Alfonso Jimenez Diaz V, McLaurin B, Hofma S, Cequier A, Dib N, Benit E, Mathur A, Brogno D, Berland J, Wykrzykowska J, Piegari G, Brugaletta S, Saito S, Leon MB; PIONEER III Trial Investigators. Novel Supreme Drug-Eluting Stents With Early Synchronized Antiproliferative Drug Delivery to Inhibit Smooth Muscle Cell Proliferation After Drug-Eluting Stents Implantation in Coronary Artery Disease: Results of the PIONEER III Randomized Clinical Trial. Circulation. 2021 Jun;143(22):2143-2154. doi: 10.1161/CIRCULATIONAHA.120.052482. Epub 2021 Apr 6.

  PMID: 33820424 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

The trial did not include all comers, e.g. ST elevation MI, left main disease or chronic total occlusion lesions, therefore, limiting generalizability of results to all patients.

Results Point of Contact

• Title: Eric Cao, VP Clinical & Regulatory affairs
• Organization: Nova Vascular

ecao@sinomed.com

408-646-1320

Study Officials

• Martin B Leon, MD

  Center for Interventional Vascular Therapy - Columbia University Medical Center / New York-Presbyterian Hospital, United States

  STUDY CHAIR

• Dean Kereiakes, MD

  The Christ Hospital Physicians - Ohio Heart & Vascular, United States

  PRINCIPAL INVESTIGATOR

• Stephan Windecker, MD

  Bern University Hospital Department for Cardiology, Switzerland

  PRINCIPAL INVESTIGATOR

• Shigeru Saito, MD

  Shonan Kamakura General Hospital, Japan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 30, 2017
• Study Start: October 13, 2017
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2024
• Last Updated: January 27, 2026
• Results First Posted: January 27, 2026

Record last verified: 2026-01

Locations

CH (2); CA (2); JP (1); US (40); NL (3); GB (1); ES (5); BE (4)