A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
Recruiting
Observational Study
Cardiovascular Diseases
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 2,000 (estimated)
- Sponsor
- Translumina Therapeutics Pvt Ltd. · Industry
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About This Trial
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.
Trial Locations
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Eligibility 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 …
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