SECURE GLOBAL REGISTRY
Research type
Research Study
Full title
A Prospective, Open-Label, Multi-Country, Multi-centre, Post Market Surveillance of VIVO ISAR In Real World Patients Undergoing Percutaneous Coronary Intervention with Short Dual-Antiplatelet Therapy (Secure Global Registry).
IRAS ID
333743
Contact name
Abhishek Kumar
Contact email
Sponsor organisation
Translumina Therapeutics LLP
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
SECURE Global Registry is a multi-national, multi-centre, post-marketing study conducted in patients with a diagnosis of single or multiple coronary artery disease and are being treated with a medical device that is used to open up blocked or narrowed heart arteries named VIVO-ISAR-Polymer Free Sirolimus Eluting Coronary Stent. The study involves patients being followed up over a period of one year to observe and collect data on the safety and performance of the medical device. It is an observational study, meaning that patients will follow their routine clinical practice without any additional tests being performed beyond standard of care. This study is sponsored by Translumina Therapeutics LLP and will be conducted in France, India, Italy, Netherlands and the UK. The rationale for this registry is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent in real world coronary artery disease patients with follow-up at 1 month, 3 months and 12 months. A data collection form (case report form) will be prepared, and data will be collected in the same. Any adverse event recorded as per the form will be evaluated simultaneously to ensure continuous risk management based on the clinical data.
REC name
South West - Frenchay Research Ethics Committee
REC reference
24/SW/0031
Date of REC Opinion
11 Apr 2024
REC opinion
Further Information Favourable Opinion