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

January 8, 2026 updated by: Sino Medical Sciences Technology Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1629

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium, 2820
        • IMELDA
      • Charleroi, Belgium
        • CHU Charleroi
      • Genk, Belgium, 3600
        • Ziekenhuis Oost Limburg Genk
      • Hasselt, Belgium, 3500
        • Jessa Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N-2T9
        • Foothills Medical Centre
    • Ontario
      • Toronto, Ontario, Canada, M5B-1W8
        • St. Michael's Hospital
  • Japan
    • Kamakura City
      • Kanagawa, Kamakura City, Japan, 247-8533
        • Shonan Kamakura General Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC
      • Leeuwarden, Netherlands
        • MCL
      • Rotterdam, Netherlands
        • Maasstad Ziekenhuis
  • Spain
      • Barcelona, Spain
        • Hospital Clinic De Barcelona
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Instituto de Investigación Hospital 12 de Octubre
      • Vigo, Spain, 36312
        • Hospital Alvaro Cunqueiro
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern
      • Geneva, Switzerland, 1211
        • University Hospital Geneva HUG, Clinic for Cardiology
  • United Kingdom
      • London, United Kingdom
        • St Bartholomew'S Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Cardiology, PC
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Dignity Health - Mercy Gilbert Medical Center / Chandler Regional Medical Center
    • California
      • Los Angeles, California, United States, 90048
        • Smidt Heart Institute Cedars-Sinai Maedical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Washington HWospital Center
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Bethesda Hospital East/Daniel Heart and Vascular Center
      • Clearwater, Florida, United States, 33756
        • Clearwater Cardiovascular Consultants
      • Ocala, Florida, United States, 34471
        • MediQuest Research Group Inc.
      • Panama City, Florida, United States, 32401
        • Cardiovascular Institute of Northwest Florida
      • Tampa, Florida, United States, 33613
        • Florida Hospital Tampa
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Krannert Institute of Cardiology
      • Indianapolis, Indiana, United States, 46290
        • St. Vincent's Medical Group
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart Center
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Norton Brownsboro Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • MedStar Union Memorial Hospital
    • Michigan
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan Hospital d.b.a. McLaren Northern Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essential Health
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North MS Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • CHI Health Research Center
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Cardiovascular Associates of Delaware Valley
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center / New York Presbyterian Hospital
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • NC Heart and Vascular Research
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
      • Cincinnati, Ohio, United States, 45219
        • Lindner Research Center
      • Elyria, Ohio, United States, 44035
        • North Ohio Heart
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Toledo, Ohio, United States, 43608
        • Mercy St. Vincent Medical Center
      • Zanesville, Ohio, United States, 43701
        • Genesis Hospital
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Clinic
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Hospital
      • Wyomissing, Pennsylvania, United States, 19610
        • Berks Cardiologists, Ltd.
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health
    • Texas
      • Tyler, Texas, United States, 75701
        • Tyler Cardiovascular Consultants
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Winchester, Virginia, United States, 22601
        • Winchester Medical Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BuMA Supreme Coronary Stent System
Device: BuMA Supreme DES
Implant BuMA Supreme stent only
Active Comparator: Xience or Promus Everolimus Stent System
Device: Xience or Promus DES
Implant XIENCE family or Promus family only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements
Time Frame: 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Cardiac Death
Time Frame: Assessed at 30 days, 6 months, 12 months, and up to 5 years
Any death due to proximate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
Assessed at 30 days, 6 months, 12 months, and up to 5 years
Number of Participants With Major Adverse Cardiac Events (MACE)
Time Frame: Assessed at 30 days, 6 months, 12 months, and up to 5 years
All-cause death, myocardial infarction, or target vessel revascularization (reported as a composite)
Assessed at 30 days, 6 months, 12 months, and up to 5 years
Number of Participants With Myocardial Infarction (MI)
Time Frame: Assessed at 30 days, 6 months, 12 months, and up to 5 years
Defined according to the modified Third Universal Definition as evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.
Assessed at 30 days, 6 months, 12 months, and up to 5 years
Number of Participants With Stent Thrombosis
Time Frame: Assessed at 30 days, 6 months, 12 months, and up to 5 years
Definite or probable (ARC-defined), classified as early, late, or very late
Assessed at 30 days, 6 months, 12 months, and up to 5 years
Number of Participants With Bleeding Complications (BARC Definitions)
Time Frame: Assessed at 30 days, 6 months, 12 months, and up to 5 years

Evaluated as components and as a composite of BARC Type 3 or 5 bleeding, including:

Type 3a: Over bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to bleed); Any transfusion with over bleeding Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL* (provided hemoglobin drop is related to bleed); Cardiac tamponade; Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid); Bleeding requiring intravenous vasoactive agents Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed comprising vision Type 5: Fatal bleeding
Assessed at 30 days, 6 months, 12 months, and up to 5 years
Lesion Success
Time Frame: Post-Procedure
Defined as attainment of <30% residual stenosis, as measured by quantitative coronary angiography (QCA) using any percutaneous method [evaluated post-procedure]
Post-Procedure
Device Success
Time Frame: Post-Procedure
Defined as attainment of <30% residual stenosis of the target lesion measured by QCA using the assigned device [evaluated post-procedure]
Post-Procedure
Procedure Success
Time Frame: Post procedure/Prior to Discharge, an average of 3 days
Defined as lesion success without the occurrence of in-hospital MACE [evaluated in-hospital]
Post procedure/Prior to Discharge, an average of 3 days
Clinically-driven Target Vessel Revascularization (TVR)
Time Frame: Assessed at 30 days, 6 months, 12 months, and up to 5 years

Any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.

A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 70% (by core lab quantitative coronary angiography assessment) OR percent diameter stenosis ≥ 50% (by core lab quantitative coronary angiography assessment) accompanied by one of the following:103

  1. a positive history of recurrent angina pectoris, presumably related to the target vessel;
  2. objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent) presumably related to the target vessel;
  3. abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve).
Assessed at 30 days, 6 months, 12 months, and up to 5 years
Target Vessel Failure (TVF)
Time Frame: Assessed at 30 days, 6 months, 12 months, and up to 5 years
The composite of cardiac death, target vessel-related myocardial infarction, and clinically-driven target vessel revascularization.
Assessed at 30 days, 6 months, 12 months, and up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sino Medical Sciences Technology Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nova Vascular LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Martin B Leon, MD, Center for Interventional Vascular Therapy - Columbia University Medical Center / New York-Presbyterian Hospital, United States
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIN-US-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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