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Clinical Trials in the UK / NCT06412250
Recruiting Observational

A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)

NCT06412250 · tracked via the Priya Life Science UK tracker
Sponsor
Translumina Therapeutics Pvt Ltd.
Phase
Observational
Started
2024-01-10
Last updated
2025-09-18

Condition(s) studied

Cardiovascular Diseases

Study summary

The objective of this post marketing observational registry is to evaluate clinical outcomes (safety and performance) in an all-comers population with coronary artery disease (CAD) treated with the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR and planned for an abbreviated (≤ 3 months) dual antiplatelet therapy (DAPT) regimen.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
Zydus Hospitals Ahmedabad India Recruiting
Fortis Hospital Bangalore India Recruiting
Adesh Hospital Bathinda India Recruiting
PGIMER Chandigarh India Recruiting
National Heart Institute Delhi India Recruiting
Fortis Escorts Heart Institute & Research Centre Delhi India Recruiting
Fortis Escorts Heart Institute & Research Centre Delhi India Recruiting
Medanta-The Medicity Gurugram India Recruiting
Yashoda Hospitals Hyderabad India Recruiting
Shalby Hospital Jabalpur India Recruiting
Fortis Hospital Kalyān India Recruiting
L.P.S Institute of Cardiology Kanpur India Recruiting
Fortis Hospital Kolkata India Recruiting
Dr. Ram Manohar Lohia Hospital (RML) Lucknow India Recruiting
Seva Sadan Hospital Miraj India Recruiting
Fortis Mohali India Recruiting
Yashodha Hospital Somājigūda India Recruiting
ASREM - Regional Hospitals Campobasso Italy Recruiting
Montevergine Mercogliano AV Italy Recruiting
Clinica Mediterranea Naples Italy Recruiting
University of Padua, Padova Padova Italy Recruiting
Clinica Pierangeli Pescara Italy Recruiting
Santo Spirito Hospital Pescara Italy Recruiting
Tor Vergata University Roma Italy Recruiting
Amsterdam UMC (University Medical Centers) Amsterdam Netherlands Recruiting
Tergooi MC Hilversum Netherlands Recruiting
Viecuri MC Venlo Netherlands Recruiting
Bedford Hospital Bedford United Kingdom Recruiting
Freeman Hospital Newcastle United Kingdom Recruiting
Derriford Hospitalm Plymouth NHS Trust Plymouth United Kingdom Recruiting
Salisbury NHS Foundation Trust Salisbury United Kingdom Recruiting
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust Wigan United Kingdom Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06412250 on ClinicalTrials.gov ↗ ← All trials in the UK