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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03168776
• Other study ID #: SIN-US-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 13, 2017
• Est. completion date: September 2024

Study information

• Verified date: February 2021
• Source: Sino Medical Sciences Technology Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1632
• Est. completion date: September 2024
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• BuMA Supreme DES
Implant BuMA Supreme stent only
• Xience or Promus DES
Implant XIENCE family or Promus family only

Locations

Country	Name	City	State
Belgium	Imelda	Bonheiden
Belgium	CHU Charleroi	Charleroi
Belgium	Ziekenhuis Oost Limburg Genk	Genk
Belgium	Jessa Hospital	Hasselt
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	St. Michael's Hospital	Toronto	Ontario
Japan	Shonan Kamakura General Hospital	Kanagawa	Kamakura City
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	MCL	Leeuwarden
Netherlands	Maasstad Ziekenhuis	Rotterdam
Spain	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
Switzerland	Inselspital, Universitätsspital Bern	Bern
Switzerland	University Hospital Geneva HUG, Clinic for Cardiology	Geneva
United Kingdom	St Bartholomew's Hospital	London
United States	AnMed Health	Anderson	South Carolina
United States	Emory University Hospital	Atlanta	Georgia
United States	Medstar Union Memorial Hospital	Baltimore	Maryland
United States	Cardiology, PC	Birmingham	Alabama
United States	Bethesda Hospital East/Daniel Heart and Vascular Center	Boynton Beach	Florida
United States	Aultman Hospital	Canton	Ohio
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Lindner Research Center	Cincinnati	Ohio
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Geisinger Clinic	Danville	Pennsylvania
United States	Iowa Heart Center	Des Moines	Iowa
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Essential Health	Duluth	Minnesota
United States	North Ohio Heart	Elyria	Ohio
United States	Dignity Health - Mercy Gilbert Medical Center / Chandler Regional Medical Center	Gilbert	Arizona
United States	Cardiovascular Associates of Delaware Valley	Haddon Heights	New Jersey
United States	Krannert Institute of Cardiology	Indianapolis	Indiana
United States	St. Vincent's Medical Group	Indianapolis	Indiana
United States	Kettering Medical Center	Kettering	Ohio
United States	Smidt Heart Institute Cedars-Sinai Maedical Center	Los Angeles	California
United States	Norton Brownsboro Hospital	Louisville	Kentucky
United States	Yale University	New Haven	Connecticut
United States	Columbia University Medical Center / New York Presbyterian Hospital	New York	New York
United States	MediQuest Research Group Inc.	Ocala	Florida
United States	CHI Health Research Center	Omaha	Nebraska
United States	Cardiovascular Institute of Northwest Florida	Panama City	Florida
United States	Northern Michigan Hospital d.b.a. McLaren Northern Michigan	Petoskey	Michigan
United States	Rhode Island Hospital	Providence	Rhode Island
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Swedish Medical Center	Seattle	Washington
United States	Florida Hospital Tampa	Tampa	Florida
United States	Mercy St. Vincent Medical Center	Toledo	Ohio
United States	North MS Medical Center	Tupelo	Mississippi
United States	Tyler Cardiovascular Consultants	Tyler	Texas
United States	Medstar Washington HWospital Center	Washington	District of Columbia
United States	Winchester Medical Center	Winchester	Virginia
United States	Berks Cardiologists, Ltd.	Wyomissing	Pennsylvania
United States	Michigan Heart	Ypsilanti	Michigan
United States	Genesis Hospital	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Sino Medical Sciences Technology Inc.	Nova Vascular LLC

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Japan,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure (TLF)	defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR)	12 months
Secondary	Long-term Safety and Efficacy defined as target lesion failure (TLF) between 12 months and 5 years by landmark analysis	TLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR)	Between 12 months and 5 years
Secondary	Major adverse cardiac events (MACE)	defined as a composite of all-cause death, myocardial infarction, and target vessel revascularization	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Secondary	Mortality	classified as cardiac or non-cardiac, and reported cumulatively and individually	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Secondary	Myocardial infarction (MI)	defined according to the modified Third Universal Definition	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Secondary	Stent thrombosis	definite or probable (ARC-defined), classified as early, late, or very late	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Secondary	Bleeding complications (BARC definitions)	evaluated as components and as a composite of BARC Type 3 and 5 bleeding	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Secondary	Lesion success	defined as attainment of <30% residual stenosis, as measured by quantitative coronary angiography (QCA) using any percutaneous method [evaluated post-procedure]	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Secondary	Device success	defined as attainment of <30% residual stenosis of the target lesion measured by QCA using the assigned device [evaluated post-procedure]	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Secondary	Procedure success	defined as lesion success without the occurrence of in-hospital MACE [evaluated in-hospital]	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Secondary	Clinically-driven target lesion revascularization (TLR)	[evaluated in hospital and at 30 days, 6 months, and 1, 2, 3, 4 and 5 years]	30 days, 6 months, and 1, 2, 3, 4, and 5 years
Secondary	Clinically-driven target vessel revascularization (TVR)	[evaluated in hospital and at 30 days, 6 months, and 1, 2, 3, 4 and 5 years]	30 days, 6 months, and 1, 2, 3, 4, and 5 years
Secondary	Target vessel failure (TVF)	defined as cardiac death, target vessel-related MI, or clinically-driven target vessel revascularization [evaluated in hospital and at 30 days, 6 months, and 1, 2, 3, 4 and 5 years]	30 days, 6 months, and 1, 2, 3, 4, and 5 years
Secondary	Target Lesion Failure (TLF)	defined as cardiac death, target vessel-related MI, or clinically-driven target lesion revascularization [evaluated in hospital and at 30 days, 6 months, and 2, 3, 4 and 5 years]	30 days, 6 months, and 2, 3, 4, and 5 years