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A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry) - Trial NCT06412250

Access comprehensive clinical trial information for NCT06412250 through Pure Global AI's free database. This phase not specified trial is sponsored by Translumina Therapeutics LLP and is currently Recruiting. The study focuses on Cardiovascular Diseases. Target enrollment is 2000 participants.

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NCT06412250
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Trial Details
ClinicalTrials.gov โ€ข NCT06412250
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A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
A Prospective, Open-Label, Multi-Country, Multicentre, Observational PoSt Market SurvEillance of VIVO ISAR (Polymer-Free Sirolimus Eluting Coronary Stent System) In Real World Patients Undergoing PCI With Short Dual Antiplatelet Therapy

Study Focus

Cardiovascular Diseases

Observational

Sponsor & Location

Translumina Therapeutics LLP

Delhi,Jabalpur,Kanpur,Miraj,Somajiguda,Palermo,Amsterdam,Hilversum, India,Italy,Netherlands

Timeline & Enrollment

N/A

Jan 10, 2024

May 01, 2026

2000 participants

Primary Outcome

Ischemic endpoint,Bleeding endpoint

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 (โ‰ค 3 months) dual antiplatelet therapy (DAPT) regimen.

ICD-10 Classifications

Cardiovascular disease, unspecified
Hypertensive heart disease
Other ill-defined heart diseases
Heart disease, unspecified
Observation for other suspected cardiovascular diseases

Data Source

ClinicalTrials.gov

NCT06412250

Non-Device Trial