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A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
Sponsor: Translumina Therapeutics Pvt Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2024-01-10
Completion Date
2027-11
Last Updated
2025-09-18
Healthy Volunteers
No
Conditions
Locations (32)
Zydus Hospitals
Ahmedabad, India
Fortis Hospital
Bangalore, India
Adesh Hospital
Bathinda, India
PGIMER
Chandigarh, India
National Heart Institute
Delhi, India
Fortis Escorts Heart Institute & Research Centre
Delhi, India
Fortis Escorts Heart Institute & Research Centre
Delhi, India
Medanta-The Medicity
Gurugram, India
Yashoda Hospitals
Hyderabad, India
Shalby Hospital
Jabalpur, India
Fortis Hospital
Kalyān, India
L.P.S Institute of Cardiology
Kanpur, India
Fortis Hospital
Kolkata, India
Dr. Ram Manohar Lohia Hospital (RML)
Lucknow, India
Seva Sadan Hospital
Miraj, India
Fortis
Mohali, India
Yashodha Hospital
Somājigūda, India
ASREM - Regional Hospitals
Campobasso, Italy
Montevergine
Mercogliano AV, Italy
Clinica Mediterranea
Naples, Italy
University of Padua, Padova
Padova, Italy
Clinica Pierangeli
Pescara, Italy
Santo Spirito Hospital
Pescara, Italy
Tor Vergata University
Roma, Italy
Amsterdam UMC (University Medical Centers)
Amsterdam, Netherlands
Tergooi MC
Hilversum, Netherlands
Viecuri MC
Venlo, Netherlands
Bedford Hospital
Bedford, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Derriford Hospitalm Plymouth NHS Trust
Plymouth, United Kingdom
Salisbury NHS Foundation Trust
Salisbury, United Kingdom
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan, United Kingdom