PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease
NCT ID: NCT03168776
Last Updated: 2026-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1629 participants
INTERVENTIONAL
2017-10-13
2024-10-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BuMA Supreme Coronary Stent System
BuMA Supreme DES
Implant BuMA Supreme stent only
Xience or Promus Everolimus Stent System
Xience or Promus DES
Implant XIENCE family or Promus family only
Interventions
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BuMA Supreme DES
Implant BuMA Supreme stent only
Xience or Promus DES
Implant XIENCE family or Promus family only
Eligibility Criteria
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Inclusion Criteria
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
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.
11. 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.
12. 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.
13. Current participation in another investigational drug or device study.
20 Years
ALL
No
Sponsors
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Nova Vascular LLC
UNKNOWN
Sino Medical Sciences Technology Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Martin B Leon, MD
Role: STUDY_CHAIR
Center for Interventional Vascular Therapy - Columbia University Medical Center / New York-Presbyterian Hospital, United States
Dean Kereiakes, MD
Role: PRINCIPAL_INVESTIGATOR
The Christ Hospital Physicians - Ohio Heart & Vascular, United States
Stephan Windecker, MD
Role: PRINCIPAL_INVESTIGATOR
Bern University Hospital Department for Cardiology, Switzerland
Shigeru Saito, MD
Role: PRINCIPAL_INVESTIGATOR
Shonan Kamakura General Hospital, Japan
Locations
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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
Emory University Hospital
Atlanta, Georgia, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, United States
St. Vincent's Medical Group
Indianapolis, Indiana, United States
Iowa Heart Center
Des Moines, Iowa, United States
Norton Brownsboro Hospital
Louisville, Kentucky, United States
Medstar Union Memorial Hospital
Baltimore, Maryland, United States
Northern Michigan Hospital d.b.a. McLaren Northern Michigan
Petoskey, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Essential Health
Duluth, Minnesota, United States
North MS Medical Center
Tupelo, Mississippi, United States
CHI Health Research Center
Omaha, Nebraska, United States
Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, United States
Columbia University Medical Center / New York Presbyterian Hospital
New York, New York, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
Lindner Research Center
Cincinnati, Ohio, United States
North Ohio Heart
Elyria, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, United States
Genesis Hospital
Zanesville, Ohio, United States
Geisinger Clinic
Danville, Pennsylvania, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
Berks Cardiologists, Ltd.
Wyomissing, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
AnMed Health
Anderson, South Carolina, United States
Tyler Cardiovascular Consultants
Tyler, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Winchester Medical Center
Winchester, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Imelda
Bonheiden, , Belgium
CHU Charleroi
Charleroi, , Belgium
Ziekenhuis Oost Limburg Genk
Genk, , Belgium
Jessa Hospital
Hasselt, , Belgium
Foothills Medical Centre
Calgary, Alberta, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Shonan Kamakura General Hospital
Kanagawa, Kamakura City, Japan
Amsterdam UMC
Amsterdam, , Netherlands
MCL
Leeuwarden, , Netherlands
Maasstad Ziekenhuis
Rotterdam, , Netherlands
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Instituto de Investigación Hospital 12 de Octubre
Madrid, , Spain
Hospital Álvaro Cunqueiro
Vigo, , Spain
Inselspital, Universitätsspital Bern
Bern, , Switzerland
University Hospital Geneva HUG, Clinic for Cardiology
Geneva, , Switzerland
St Bartholomew's Hospital
London, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SIN-US-001
Identifier Type: -
Identifier Source: org_study_id
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