NCT06412250 A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
| NCT ID | NCT06412250 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Translumina Therapeutics Pvt Ltd. |
| Condition | Cardiovascular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-01-10 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2024-01-10 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR and planned for an abbreviated (≤ 3 months) dual antiplatelet therapy (DAPT) regimen.
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 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
Contact & Investigator
Prof Adnan Kastrati
STUDY CHAIR
German Heart Centre Munich, Germany
Frequently Asked Questions
Who can join the NCT06412250 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06412250 currently recruiting?
Yes, NCT06412250 is actively recruiting participants. Contact the research team at diptenduchatterjee@translumina.in for enrollment information.
Where is the NCT06412250 trial being conducted?
This trial is being conducted at Ahmedabad, India, Bangalore, India, Bathinda, India, Chandigarh, India and 11 additional locations.
Who is sponsoring the NCT06412250 clinical trial?
NCT06412250 is sponsored by Translumina Therapeutics Pvt Ltd.. The principal investigator is Prof Adnan Kastrati at German Heart Centre Munich, Germany. The trial plans to enroll 2,000 participants.