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Coronary Artery DiseaseNCT03168776

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

A study testing BuMA Supreme DES and Xience or Promus DES in people with Coronary Artery Disease, run by Sino Medical Sciences Technology Inc. at 58 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
BuMA Supreme DES and Xience or Promus DES
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,629 participants
Where
58 sitesin 8 countries
Study dates
13 Oct 2017to 1 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is a male or non-pregnant female ≥20 years of age.
  • 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).
  • The patient is an acceptable candidate for percutaneous coronary intervention (PCI) with drug-eluting stents, and for emergent coronary bypass graft (CABG) surgery.
  • The patient is willing to comply with specified follow-up evaluations.
  • 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).

Who cannot join

  • 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.
  • Patients with a history of bleeding diathesis or coagulopathy, contraindications to anti-platelet and/or anticoagulant therapy, or who will refuse transfusion.
  • Patients who are receiving or will require chronic anticoagulation therapy for any reason.
  • 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.
  • ST-segment elevation myocardial infarction (STEMI) at index presentation or within 7 days prior to randomization.
  • 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).
Show all 13Show fewer
  • 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.
  • Target vessel percutaneous coronary intervention with stent placement in the previous 3 months.
  • Planned elective surgery that would require discontinuation of DAPT within 6 months of the index procedure.
  • Past or pending heart or any other organ transplant, or on the waiting list for any organ transplant.
  • 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.
  • 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.
  • Current participation in another investigational drug or device study.

Trial locations and contacts

58 sites in 8 countries.

58 sites in 8 countries

United States40 sites

  • AnMed Health

    Anderson, South Carolina, 29621

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Cardiology, PC

    Birmingham, Alabama, 35211

  • Bethesda Hospital East/Daniel Heart and Vascular Center

    Boynton Beach, Florida, 33435

  • Aultman Hospital

    Canton, Ohio, 44710

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Lindner Research Center

    Cincinnati, Ohio, 45219

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756

  • Geisinger Clinic

    Danville, Pennsylvania, 17822

  • Iowa Heart Center

    Des Moines, Iowa, 50314

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Essential Health

    Duluth, Minnesota, 55805

  • North Ohio Heart

    Elyria, Ohio, 44035

  • Dignity Health - Mercy Gilbert Medical Center / Chandler Regional Medical Center

    Gilbert, Arizona, 85297

  • Cardiovascular Associates of Delaware Valley

    Haddon Heights, New Jersey, 08035

  • Krannert Institute of Cardiology

    Indianapolis, Indiana, 46202

  • St. Vincent's Medical Group

    Indianapolis, Indiana, 46290

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Smidt Heart Institute Cedars-Sinai Maedical Center

    Los Angeles, California, 90048

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241

  • Yale University

    New Haven, Connecticut, 06520

  • Columbia University Medical Center / New York Presbyterian Hospital

    New York, New York, 10032

  • MediQuest Research Group Inc.

    Ocala, Florida, 34471

  • CHI Health Research Center

    Omaha, Nebraska, 68124

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32401

  • Northern Michigan Hospital d.b.a. McLaren Northern Michigan

    Petoskey, Michigan, 49770

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Florida Hospital Tampa

    Tampa, Florida, 33613

  • Mercy St. Vincent Medical Center

    Toledo, Ohio, 43608

  • North MS Medical Center

    Tupelo, Mississippi, 38801

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701

  • Medstar Washington HWospital Center

    Washington D.C., District of Columbia, 20010

  • Winchester Medical Center

    Winchester, Virginia, 22601

  • Berks Cardiologists, Ltd.

    Wyomissing, Pennsylvania, 19610

  • Michigan Heart

    Ypsilanti, Michigan, 48197

  • Genesis Hospital

    Zanesville, Ohio, 43701

Other trials in United States

Spain5 sites

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital Universitari de Bellvitge

    Barcelona

  • Hospital Ramon y Cajal

    Madrid

  • Instituto de Investigación Hospital 12 de Octubre

    Madrid

  • Hospital Álvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

Belgium4 sites

  • Imelda

    Bonheiden, 2820

  • CHU Charleroi

    Charleroi

  • Ziekenhuis Oost Limburg Genk

    Genk, 3600

  • Jessa Hospital

    Hasselt, 3500

Other trials in Belgium

Netherlands3 sites

  • Amsterdam UMC

    Amsterdam

  • MCL

    Leeuwarden

  • Maasstad Ziekenhuis

    Rotterdam

Other trials in Netherlands

Canada2 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N-2T9

  • St. Michael's Hospital

    Toronto, Ontario, M5B-1W8

Other trials in Canada

Switzerland2 sites

  • Inselspital, Universitätsspital Bern

    Bern, 3010

  • University Hospital Geneva HUG, Clinic for Cardiology

    Geneva, 1211

Other trials in Switzerland

Japan1 site

  • Shonan Kamakura General Hospital

    Kanagawa, Kamakura City, 247-8533

Other trials in Japan

United Kingdom1 site

  • St Bartholomew's Hospital

    London

Other trials in United Kingdom

About this study

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

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.

Being tested
BuMA Supreme DES, Xience or Promus DES
Keywords
Drug-eluting stent
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BuMA Supreme DESDevice

    Implant BuMA Supreme stent only

  • Xience or Promus DESDevice

    Implant XIENCE family or Promus family only

Study groups in NCT03168776
Study groupRoleWhat they receive
BuMA Supreme Coronary Stent SystemExperimentalNot described
Receives: Device: BuMA Supreme DES
Xience or Promus Everolimus Stent SystemActive comparatorNot described
Receives: Device: Xience or Promus DES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements

    TLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR)

    Measured: 12 months

Secondary outcomes (10)

  1. Number of Participants With Cardiac Death

    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.

    Measured: Assessed at 30 days, 6 months, 12 months, and up to 5 years

  2. Number of Participants With Major Adverse Cardiac Events (MACE)

    All-cause death, myocardial infarction, or target vessel revascularization (reported as a composite)

    Measured: Assessed at 30 days, 6 months, 12 months, and up to 5 years

  3. Number of Participants With Myocardial Infarction (MI)

    Defined according to the modified Third Universal Definition as evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.

    Measured: Assessed at 30 days, 6 months, 12 months, and up to 5 years

  4. Number of Participants With Stent Thrombosis

    Definite or probable (ARC-defined), classified as early, late, or very late

    Measured: Assessed at 30 days, 6 months, 12 months, and up to 5 years

  5. Number of Participants With Bleeding Complications (BARC Definitions)

    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

    Measured: Assessed at 30 days, 6 months, 12 months, and up to 5 years

  6. Lesion Success

    Defined as attainment of <30% residual stenosis, as measured by quantitative coronary angiography (QCA) using any percutaneous method [evaluated post-procedure]

    Measured: Post-Procedure

  7. Device Success

    Defined as attainment of <30% residual stenosis of the target lesion measured by QCA using the assigned device [evaluated post-procedure]

    Measured: Post-Procedure

  8. Procedure Success

    Defined as lesion success without the occurrence of in-hospital MACE [evaluated in-hospital]

    Measured: Post procedure/Prior to Discharge, an average of 3 days

  9. Clinically-driven Target Vessel Revascularization (TVR)

    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).

    Measured: Assessed at 30 days, 6 months, 12 months, and up to 5 years

  10. Target Vessel Failure (TVF)

    The composite of cardiac death, target vessel-related myocardial infarction, and clinically-driven target vessel revascularization.

    Measured: Assessed at 30 days, 6 months, 12 months, and up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study start13 Oct 2017
  3. Primary completion1 Oct 2020
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,629 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03168776
Sponsor's protocol ID
SIN-US-001
Status last verified
Jan 2026
First submitted
23 May 2017
Last updated
27 Jan 2026
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33820424

Questions about this trial

What is this clinical trial studying?

A study testing BuMA Supreme DES and Xience or Promus DES in people with Coronary Artery Disease, run by Sino Medical Sciences Technology Inc. at 58 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Spain, Belgium, Netherlands, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03168776, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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