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New dissolving stent could improve heart artery treatment

NCT ID NCT03168776

Disease control Sponsor: Sino Medical Sciences Technology Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tested a new type of stent (a small mesh tube) that slowly dissolves after being placed in a heart artery. The stent is coated with a drug to prevent the artery from narrowing again. Over 1600 patients with stable heart disease or a mild heart attack received either the new stent or a standard permanent stent. Researchers tracked heart-related deaths, heart attacks, and the need for repeat procedures for up to 5 years to see if the new stent is safer and works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BuMA Supreme biodegradable drug-coated coronary stent
What this could lead to
If successful, this could provide a safer, more effective option for opening blocked heart arteries, potentially reducing long-term complications.
What could go wrong
This is a completed trial comparing two stents, so results are known. However, the new stent may not prove superior to existing ones, and any stent carries risks like blood clots or re-narrowing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,629 people

The number who actually took part.

Started

Oct 2017

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

Contacts and locations

Locations

  • Amsterdam UMC

    Amsterdam, Netherlands

  • AnMed Health

    Anderson, South Carolina, 29621, United States

  • Aultman Hospital

    Canton, Ohio, 44710, United States

  • Berks Cardiologists, Ltd.

    Wyomissing, Pennsylvania, 19610, United States

  • Bethesda Hospital East/Daniel Heart and Vascular Center

    Boynton Beach, Florida, 33435, United States

  • CHI Health Research Center

    Omaha, Nebraska, 68124, United States

  • CHU Charleroi

    Charleroi, Belgium

  • Cardiology, PC

    Birmingham, Alabama, 35211, United States

  • Cardiovascular Associates of Delaware Valley

    Haddon Heights, New Jersey, 08035, United States

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32401, United States

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756, United States

  • Columbia University Medical Center / New York Presbyterian Hospital

    New York, New York, 10032, United States

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

    Gilbert, Arizona, 85297, United States

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Essential Health

    Duluth, Minnesota, 55805, United States

  • Florida Hospital Tampa

    Tampa, Florida, 33613, United States

  • Foothills Medical Centre

    Calgary, Alberta, T2N-2T9, Canada

  • Geisinger Clinic

    Danville, Pennsylvania, 17822, United States

  • Genesis Hospital

    Zanesville, Ohio, 43701, United States

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital Ramon y Cajal

    Madrid, Spain

  • Hospital Universitari de Bellvitge

    Barcelona, Spain

  • Hospital Álvaro Cunqueiro

    Vigo, 36312, Spain

  • Imelda

    Bonheiden, 2820, Belgium

  • Inselspital, Universitätsspital Bern

    Bern, 3010, Switzerland

  • Instituto de Investigación Hospital 12 de Octubre

    Madrid, Spain

  • Iowa Heart Center

    Des Moines, Iowa, 50314, United States

  • Jessa Hospital

    Hasselt, 3500, Belgium

  • Kettering Medical Center

    Kettering, Ohio, 45429, United States

  • Krannert Institute of Cardiology

    Indianapolis, Indiana, 46202, United States

  • Lindner Research Center

    Cincinnati, Ohio, 45219, United States

  • MCL

    Leeuwarden, Netherlands

  • Maasstad Ziekenhuis

    Rotterdam, Netherlands

  • MediQuest Research Group Inc.

    Ocala, Florida, 34471, United States

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21218, United States

  • Medstar Washington HWospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Mercy St. Vincent Medical Center

    Toledo, Ohio, 43608, United States

  • Michigan Heart

    Ypsilanti, Michigan, 48197, United States

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607, United States

  • North MS Medical Center

    Tupelo, Mississippi, 38801, United States

  • North Ohio Heart

    Elyria, Ohio, 44035, United States

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

    Petoskey, Michigan, 49770, United States

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Shonan Kamakura General Hospital

    Kanagawa, Kamakura City, 247-8533, Japan

  • Smidt Heart Institute Cedars-Sinai Maedical Center

    Los Angeles, California, 90048, United States

  • St Bartholomew's Hospital

    London, United Kingdom

  • St. Michael's Hospital

    Toronto, Ontario, M5B-1W8, Canada

  • St. Vincent's Medical Group

    Indianapolis, Indiana, 46290, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701, United States

  • University Hospital Geneva HUG, Clinic for Cardiology

    Geneva, 1211, Switzerland

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073, United States

  • Winchester Medical Center

    Winchester, Virginia, 22601, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

  • Ziekenhuis Oost Limburg Genk

    Genk, 3600, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.