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NCT06412250Recruiting

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
Translumina Therapeutics LLPClinicalTrials.gov
Verified
Study focus
Disease/Condition
Cardiovascular Diseases
Study type
Observational
Sponsor & location
Primary sponsor
Translumina Therapeutics LLP
Location
Delhi,Jabalpur,Kanpur,Miraj,Somajiguda,Palermo,Amsterdam,Hilversum, India,Italy,Netherlands
Timeline & enrollment
Phase
N/A
Start date
Jan 10, 2024
End date
May 01, 2026
Enrollment
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 (≤ 3 months) dual antiplatelet therapy (DAPT) regimen.

ICD-10 classifications
Cardiovascular disease, unspecifiedHypertensive heart diseaseOther ill-defined heart diseasesHeart disease, unspecifiedObservation for other suspected cardiovascular diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06412250
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.