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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 February 2021
• Main ID: NCT03168776
• Date of registration: 23/05/2017
• Prospective Registration: Yes
• Primary sponsor: Sino Medical Sciences Technology Inc.
• Public title: PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease
• Scientific 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
• Date of first enrolment: October 13, 2017
• Target sample size: 1632
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03168776
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

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

Contacts

• Name: Shigeru Saito, MD
• Affiliation: Shonan Kamakura General Hospital, Japan

• Name: Martin B Leon, MD
• Affiliation: Center for Interventional Vascular Therapy - Columbia University Medical Center / New York-Presbyterian Hospital, United States

• Name: Stephan Windecker, MD
• Affiliation: Bern University Hospital Department for Cardiology, Switzerland

• Name: Dean Kereiakes, MD
• Affiliation: The Christ Hospital Physicians - Ohio Heart & Vascular, United States

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Device: Xience or Promus DES

Device: BuMA Supreme DES

Primary Outcome(s)

Target lesion failure (TLF) [Time Frame: 12 months]

Secondary Outcome(s)

Long-term Safety and Efficacy defined as target lesion failure (TLF) between 12 months and 5 years by landmark analysis [Time Frame: Between 12 months and 5 years]

Clinically-driven target lesion revascularization (TLR) [Time Frame: 30 days, 6 months, and 1, 2, 3, 4, and 5 years]

Target Lesion Failure (TLF) [Time Frame: 30 days, 6 months, and 2, 3, 4, and 5 years]

Mortality [Time Frame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years]

Clinically-driven target vessel revascularization (TVR) [Time Frame: 30 days, 6 months, and 1, 2, 3, 4, and 5 years]

Device success [Time Frame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years]

Myocardial infarction (MI) [Time Frame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years]

Target vessel failure (TVF) [Time Frame: 30 days, 6 months, and 1, 2, 3, 4, and 5 years]

Lesion success [Time Frame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years]

Procedure success [Time Frame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years]

Bleeding complications (BARC definitions) [Time Frame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years]

Stent thrombosis [Time Frame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years]

Major adverse cardiac events (MACE) [Time Frame: 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years]

Secondary ID(s)

SIN-US-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nova Vascular LLC