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

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

Conditions2

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