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New heart stent aims to cut blood thinner time, lower bleeding risk

NCT ID NCT06412250

Disease control Sponsor: Translumina Therapeutics Pvt Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is tracking 2,000 heart disease patients who receive the VIVO ISAR stent, a drug-coated device that releases medication to keep arteries open. Participants will take blood thinners for three months or less after the procedure. Researchers are monitoring for heart attacks, stent clots, and major bleeding to see if this shorter treatment is safe and effective.

What this could mean

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

Active substance
VIVO ISAR polymer-free sirolimus-eluting coronary stent
What this could lead to
If successful, this could show that the VIVO ISAR stent is safe and effective with a shorter course of blood thinners, potentially reducing bleeding risks for heart disease patients.
What could go wrong
This is an observational registry, not a controlled trial, so results may be influenced by patient selection. The short blood thinner regimen may increase the risk of stent-related blood clots or heart attacks.

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

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

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

A real-world population undergoing percutaneous coronary intervention with VIVO-ISAR (Polymer Free Sirolimus Eluting Coronary Stent) and intended for treatment with ≤ 3 months of DAPT

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. Ability to provide written informed consent. 2. Treated only with the VIVO ISAR stent system. 3. ≥ 18 years old. 4. Male or non-pregnant female patient. 5. Intended for treatment with ≤ 3 months DAPT after PCI as per standard of care. Exclusion Criteria: 1. Patients having any of the following conditions will not be considered (enrolled) for the study Concurrent participation in an interventional study. 2. Cardiogenic shock/hemodynamic instability around the time of the index procedure. 3. Concurrent medical condition with a life expectancy of less than 12 months. 4. Allergy or contraindication to antiplatelet therapy, cobalt chromium, sirolimus or any known hypersensitivity to the planned anti-platelet drugs. 5. History of cerebrovascular accident in the last 6 months. 6. Pregnant female. 7. PCI performed within the previous 3 months from the date of index procedure 8. Treated with another stent type during the index procedure in addition to the VIVO ISAR stent system

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder coronary artery disorder

As listed by the trial registrant

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

Cardiovascular diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    32 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASREM - Regional Hospitals

    RECRUITING

    Campobasso, 86100, Italy

  • Adesh Hospital

    RECRUITING

    Bathinda, 151001, India

  • Amsterdam UMC (University Medical Centers)

    RECRUITING

    Amsterdam, 91105, Netherlands

  • Bedford Hospital

    RECRUITING

    Bedford, MK42 9DJ, United Kingdom

  • Clinica Mediterranea

    RECRUITING

    Naples, 80122, Italy

  • Clinica Pierangeli

    RECRUITING

    Pescara, 65124, Italy

  • Derriford Hospitalm Plymouth NHS Trust

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Dr. Ram Manohar Lohia Hospital (RML)

    RECRUITING

    Lucknow, 226010, India

  • Fortis

    RECRUITING

    Mohali, 160062, India

  • Fortis Escorts Heart Institute & Research Centre

    RECRUITING

    Delhi, 110025, India

  • Fortis Escorts Heart Institute & Research Centre

    RECRUITING

    Delhi, 110025, India

  • Fortis Hospital

    RECRUITING

    Bangalore, 560076, India

  • Fortis Hospital

    RECRUITING

    Kalyān, 421301, India

  • Fortis Hospital

    RECRUITING

    Kolkata, 700107, India

  • Freeman Hospital

    RECRUITING

    Newcastle, NE7 7DN, United Kingdom

  • L.P.S Institute of Cardiology

    RECRUITING

    Kanpur, 208019, India

  • Medanta-The Medicity

    RECRUITING

    Gurugram, 122001, India

  • Montevergine

    RECRUITING

    Mercogliano AV, 83013, Italy

  • National Heart Institute

    RECRUITING

    Delhi, 11 00 65, India

  • PGIMER

    RECRUITING

    Chandigarh, 160012, India

  • Salisbury NHS Foundation Trust

    RECRUITING

    Salisbury, SP2 8BJ, United Kingdom

  • Santo Spirito Hospital

    RECRUITING

    Pescara, 65124, Italy

  • Seva Sadan Hospital

    RECRUITING

    Miraj, 416410, India

    Contact Email: •••••@•••••

  • Shalby Hospital

    RECRUITING

    Jabalpur, 482002, India

  • Tergooi MC

    RECRUITING

    Hilversum, 1213 XZ, Netherlands

  • Tor Vergata University

    RECRUITING

    Roma, 00133, Italy

  • University of Padua, Padova

    RECRUITING

    Padova, 35122, Italy

  • Viecuri MC

    RECRUITING

    Venlo, 5912, Netherlands

  • Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Wigan, WN1 2NN, United Kingdom

  • Yashoda Hospitals

    RECRUITING

    Hyderabad, 500081, India

  • Yashodha Hospital

    RECRUITING

    Somājigūda, 500082, India

  • Zydus Hospitals

    RECRUITING

    Ahmedabad, 380054, India

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