Heart stent passes Real-World test: orsiro keeps arteries open

NCT ID NCT04175626

Disease control Sponsor: Biotronik, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 556 people with coronary artery disease to confirm that the Orsiro drug-eluting stent is safe and effective in everyday use. The stent releases sirolimus to prevent artery re-narrowing. Researchers tracked how many patients had heart-related death, heart attack, or needed another procedure within 12 months.

What this could mean

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

Active substance: Orsiro sirolimus-eluting coronary stent (a metal stent coated with the drug sirolimus)
What this could lead to: If successful, this confirms that the Orsiro stent works well in everyday patients, offering a reliable option to keep heart arteries open and reduce the need for repeat procedures.
What could go wrong: This is a post-approval study confirming earlier results, not a new breakthrough. Stents still carry risks like blood clots or re-narrowing, and results may vary in complex cases.

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.

Participants

556 people

The number who actually took part.

Started

Jan 2020

Finished

Jan 2026

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.

Who is studied

Subjects with coronary artery disease (CAD), including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of ≤ 36 mm.

Ages

18 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. Subject is ≥18 years of age. 2. Subject was an acceptable candidate for treatment with a drug eluting stent at the qualifying index procedure, in accordance with the applicable guidelines on percutaneous coronary interventions and manufacturer's Instructions for Use. 3. Subject received at least one Orsiro stent during an index procedure occurring within 24 hours prior to informed consent, as assessed by the end time of procedure. If more than one stent was implanted during the index procedure, all stents were Orsiro stents. 4. Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine. 5. Subject is willing to comply with study follow-up requirements. 6. Subject has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. Legally authorized representatives are not allowed to consent on a subject's behalf. Each target lesion/vessel must have met all of the following angiographic criteria from the index procedure for the subject to be eligible for the trial: 1. Subject has up to three target lesions in up to two separate target vessels (two target lesions in one vessel and one target lesion in a separate vessel). 2. Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only. 3. Target lesion must be in major coronary artery or branch (target vessel). 4. Target lesion must have angiographic evidence of ≥ 50% and \< 100% stenosis (by operator visual estimate). If the target lesion is \< 70% stenosed, there should be clinical evidence of ischemia. 5. Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow \> 1. 6. Target lesion must be ≤ 36 mm in length by operator visual estimate. 7. Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate. 8. Target lesion must have been treated with a maximum of two overlapping stents. Exclusion Criteria: 1. Subject had clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI) within 72 hours prior to the index procedure. 2. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study. 3. Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), silicon carbide, PLLA, sirolimus. 4. Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure or any PCI planned within the next 1 year. 5. Presence of an untreated clinically significant stenosis post-procedure whether treatment is planned or not. 6. Planned surgery within 6 months of index procedure unless DAPT can be maintained throughout the peri-surgical period. 7. History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure. 8. Subject has documented LVEF \< 30% prior to consent. 9. Subject is dialysis-dependent. 10. Subject has impaired renal function (blood creatinine \> 2.5 mg/dL or 221 μmol/L prior to the index procedure). 11. Subject has leukopenia (i.e. \< 3,000 white blood cells/mm3), thrombocytopenia (i.e. \< 100,000 platelets/mm3) or thrombocytosis (i.e. \> 700,000 platelet/mm3). 12. Any significant concurrent medical diagnosis that would potentially impact DAPT effectiveness or increase thrombotic risk. 13. Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent). 14. Subject has life expectancy of \< 1 year. 15. Subject is participating in an investigational (medical device or drug) clinical study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the follow-up requirements of this study or does not involve a drug that may confound the interpretation of any relevant clinical events of interest (e.g. investigational DAPT therapy). 16. In the investigator's opinion, subject will not be able to comply with the follow-up requirements. Subjects will be excluded from the trial if any of the target lesions/vessels met any of the following angiographic criteria during the index procedure: 1. Target lesion was located within or treated through a saphenous vein graft or arterial graft. 2. Target lesion was a restenotic lesion that was previously treated with a bare metal or drug-eluting stent (in-stent restenosis). 3. Target lesion had any of the following characteristics: 1. Lesion location is within the left main coronary artery, or within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX). 2. Involves a side branch of \> 2.0 mm in diameter. 4. Target vessel/lesion was excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation. 5. Target vessel had angiographic evidence of thrombus. 6. Target lesion was totally occluded (100% stenosis). 7. Target vessel was treated with brachytherapy any time prior to the index procedure.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome Angina Pectoris coronary artery disorder coronary atherosclerosis intermediate coronary syndrome myocardial ischemia

As listed by the trial registrant

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

Acute coronary syndrome Angina pectoris Atherosclerosis, coronary Coronary artery disease Ischemic heart disease Myocardial ischemia

Contacts and locations

Locations

AdventHealth Tampa

Tampa, Florida, 33613, United States
Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States
AnMed Health

Anderson, South Carolina, 29621, United States
Ascension St. Vincent Medical Group

Indianapolis, Indiana, 46920, United States
Ascension Via Christi Hospitals

Wichita, Kansas, 67226, United States
Austin Heart

Austin, Texas, 78756, United States
Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States
Baystate Medical Center

Springfield, Massachusetts, 01199, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Cardiology Associates of Mobile

Fairhope, Alabama, 36532, United States
Charleston Area Medical Center Memorial Hospital

Charleston, West Virginia, 25304, United States
Columbia University Medical Center

New York, New York, 10032, United States
John Muir Medical Center

Concord, California, 94520, United States
Maimonides Medical Center

Brooklyn, New York, 11219, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Mercy Health - St Vincent Medical Center

Toledo, Ohio, 43608, United States
Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States
Northern Light Cardiology

Bangor, Maine, 04401, United States
Penn State Health Holy Spirit Medical Center

Camp Hill, Pennsylvania, 17011, United States
Piedmont Heart Institute

Atlanta, Georgia, 30309, United States
Saint Michael's Medical Center

Newark, New Jersey, 07102, United States
Seton Medical Center Austin

Austin, Texas, 78705, United States
St. Joseph Hospital Orange

Orange, California, 92868, United States
UT Health Science Center

Houston, Texas, 77030, United States
University of Chicago Medical Center

Chicago, Illinois, 60637, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Kentucky

Lexington, Kentucky, 40536, United States
University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States
University of Virginia Health System

Charlottesville, Virginia, 22908, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Weill Cornell Medical College

New York, New York, 10065, United States

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