Clinical trial NCT03168776: PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Drug-eluting stent
Lead sponsor: Sino Medical Sciences Technology Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nova Vascular LLC
First posted: 2017-05-30
Enrollment: 1632
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.
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.

Primary outcomes:
measure: Target lesion failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Long-term Safety and Efficacy defined as target lesion failure (TLF) between 12 months and 5 years by landmark analysis
timeFrame: Between 12 months and 5 years
measure: Major adverse cardiac events (MACE)
timeFrame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
measure: Mortality
timeFrame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
measure: Myocardial infarction (MI)
timeFrame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
measure: Stent thrombosis
timeFrame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
measure: Bleeding complications (BARC definitions)
timeFrame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
measure: Lesion success
timeFrame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
measure: Device success
timeFrame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
measure: Procedure success
timeFrame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
measure: Clinically-driven target lesion revascularization (TLR)
timeFrame: 30 days, 6 months, and 1, 2, 3, 4, and 5 years
measure: Clinically-driven target vessel revascularization (TVR)
timeFrame: 30 days, 6 months, and 1, 2, 3, 4, and 5 years
measure: Target vessel failure (TVF)
timeFrame: 30 days, 6 months, and 1, 2, 3, 4, and 5 years
measure: Target Lesion Failure (TLF)
timeFrame: 30 days, 6 months, and 2, 3, 4, and 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology, PC
state: Alabama
city: Gilbert
country: United States
facility: Dignity Health - Mercy Gilbert Medical Center / Chandler Regional Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Smidt Heart Institute Cedars-Sinai Maedical Center
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Medstar Washington HWospital Center
state: District of Columbia
city: Boynton Beach
country: United States
facility: Bethesda Hospital East/Daniel Heart and Vascular Center
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Ocala
country: United States
facility: MediQuest Research Group Inc.
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute of Northwest Florida
state: Florida
city: Tampa
country: United States
facility: Florida Hospital Tampa
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent's Medical Group
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Louisville
country: United States
facility: Norton Brownsboro Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
city: Petoskey
country: United States
facility: Northern Michigan Hospital d.b.a. McLaren Northern Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Duluth
country: United States
facility: Essential Health
state: Minnesota
city: Tupelo
country: United States
facility: North MS Medical Center
state: Mississippi
city: Omaha
country: United States
facility: CHI Health Research Center
state: Nebraska
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of Delaware Valley
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center / New York Presbyterian Hospital
state: New York
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Lindner Research Center
state: Ohio
city: Elyria
country: United States
facility: North Ohio Heart
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent Medical Center
state: Ohio
city: Zanesville
country: United States
facility: Genesis Hospital
state: Ohio
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists, Ltd.
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Tyler
country: United States
facility: Tyler Cardiovascular Consultants
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Bonheiden
country: Belgium
facility: Imelda
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg Genk
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Kanagawa
country: Japan
facility: Shonan Kamakura General Hospital
state: Kamakura City
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Leeuwarden
country: Netherlands
facility: MCL
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Instituto de Investigación Hospital 12 de Octubre
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
city: Geneva
country: Switzerland
facility: University Hospital Geneva HUG, Clinic for Cardiology
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
affiliation: Center for Interventional Vascular Therapy - Columbia University Medical Center / New York-Presbyterian Hospital, United States
name: Martin B Leon, MD
role: STUDY_CHAIR
affiliation: The Christ Hospital Physicians - Ohio Heart & Vascular, United States
name: Dean Kereiakes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bern University Hospital Department for Cardiology, Switzerland
name: Stephan Windecker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shonan Kamakura General Hospital, Japan
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.