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Registry to evaluate safety and performance of Vivo ISAR stent in coronary artery disease patients

A Prospective, Open-Label, Multi-Country, Multicentre, Observational PoSt Market SurvEillance of VIVO ISAR (Polymer-Free Sirolimus Eluting Coronary Stent System) In Real World Patients Undergoing PCI With Short Dual Antiplatelet Therapy

Observational Translumina Therapeutics Pvt Ltd. · NCT06412250

This study is testing how safe and effective the Vivo ISAR stent is for people with coronary artery disease who are receiving standard treatment.

Quick facts

Study typeObservational
Enrollment2000 (estimated)
Ages18 Years and up
SexAll
SponsorTranslumina Therapeutics Pvt Ltd. Industry-sponsored
Locations32 sites (Ahmedabad and 31 other locations)
Trial IDNCT06412250 on ClinicalTrials.gov

What this trial studies

This observational registry aims to assess the clinical outcomes, specifically safety and performance, of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease (CAD). Participants will be treated with the Vivo ISAR stent and will receive a standard of care abbreviated dual antiplatelet therapy (DAPT) for up to three months. The study will involve multiple centers across different countries, with follow-up assessments conducted at 1 month, 3 months, and 12 months post-procedure. Data will be collected through medical notes and telephonic follow-ups to monitor patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this registry are adults aged 18 and older who are undergoing PCI with the Vivo ISAR stent and are planned to receive ≤ 3 months of DAPT.

Not a fit: Patients with contraindications to antiplatelet therapy or those with concurrent medical conditions affecting life expectancy may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of the Vivo ISAR stent, potentially improving treatment options for patients with coronary artery disease.

How similar studies have performed: Other studies evaluating similar stent technologies have shown promising results, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Ahmedabad and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cardiovascular Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.