Clinical Trials in Italy / 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 Italy tracker
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
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)
- Ischemic endpoint — 12 months
Cardiovascular death, myocardial infarction (not clearly attributable to a non-target vessel), definite or probable stent thrombosis or urgent target lesion revascularization (TLR). - Bleeding endpoint — 12 months
bleeding defined as Bleeding Academic Research Consortium (BARC) class 3 or higher
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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 Italy