Status:
RECRUITING
A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
Lead Sponsor:
Translumina Therapeutics Pvt Ltd.
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Brief 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 Po...
Detailed Description
This study is a prospective, observational, multi-country, multi-Centre, single-arm registry designed to evaluate the clinical safety and performance of VIVO ISAR, Polymer Free Sirolimus Eluting Coron...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent.
- Treated only with the VIVO ISAR stent system.
- ≥ 18 years old.
- Male or non-pregnant female patient.
- Intended for treatment with ≤ 3 months DAPT after PCI as per standard of care.
Exclusion
- Patients having any of the following conditions will not be considered (enrolled) for the study Concurrent participation in an interventional study.
- Cardiogenic shock/hemodynamic instability around the time of the index procedure.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Allergy or contraindication to antiplatelet therapy, cobalt chromium, sirolimus or any known hypersensitivity to the planned anti-platelet drugs.
- History of cerebrovascular accident in the last 6 months.
- Pregnant female.
- PCI performed within the previous 3 months from the date of index procedure
- Treated with another stent type during the index procedure in addition to the VIVO ISAR stent system
Key Trial Info
Start Date :
January 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06412250
Start Date
January 10 2024
End Date
November 1 2027
Last Update
September 18 2025
Active Locations (32)
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1
Zydus Hospitals
Ahmedabad, India, 380054
2
Fortis Hospital
Bangalore, India, 560076
3
Adesh Hospital
Bathinda, India, 151001
4
PGIMER
Chandigarh, India, 160012