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
Status: Recruiting
Location: See all (32) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Ability to provide written informed consent.
• Treated only with the VIVO ISAR stent system.
• ≥ 18 years old.
• Male or non-pregnant female patient.
• Intended for treatment with ≤ 3 months DAPT after PCI as per standard of care.
Locations
Other Locations
India
Zydus Hospitals
RECRUITING
Ahmedabad
Fortis Hospital
RECRUITING
Bangalore
Adesh Hospital
RECRUITING
Bathinda
PGIMER
RECRUITING
Chandigarh
Fortis Escorts Heart Institute & Research Centre
RECRUITING
Delhi
Fortis Escorts Heart Institute & Research Centre
RECRUITING
Delhi
National Heart Institute
RECRUITING
Delhi
Medanta-The Medicity
RECRUITING
Gurugram
Yashoda Hospitals
RECRUITING
Hyderabad
Shalby Hospital
RECRUITING
Jabalpur
Fortis Hospital
RECRUITING
Kalyān
L.P.S Institute of Cardiology
RECRUITING
Kanpur
Fortis Hospital
RECRUITING
Kolkata
Dr. Ram Manohar Lohia Hospital (RML)
RECRUITING
Lucknow
Seva Sadan Hospital
RECRUITING
Miraj
Fortis
RECRUITING
Mohali
Yashodha Hospital
RECRUITING
Somājigūda
Italy
ASREM - Regional Hospitals
RECRUITING
Campobasso
Montevergine
RECRUITING
Mercogliano Av
Clinica Mediterranea
RECRUITING
Napoli
University of Padua, Padova
RECRUITING
Padua
Clinica Pierangeli
RECRUITING
Pescara
Santo Spirito Hospital
RECRUITING
Pescara
Tor Vergata University
RECRUITING
Roma
Netherlands
Amsterdam UMC (University Medical Centers)
RECRUITING
Amsterdam
Tergooi MC
RECRUITING
Hilversum
Viecuri MC
RECRUITING
Venlo
United Kingdom
Bedford Hospital
RECRUITING
Bedford
Freeman Hospital
RECRUITING
Newcastle
Derriford Hospitalm Plymouth NHS Trust
RECRUITING
Plymouth
Salisbury NHS Foundation Trust
RECRUITING
Salisbury
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
RECRUITING
Wigan
Contact Information
Primary
Diptendu Chatterjee
diptenduchatterjee@translumina.in
9339948873
Backup
Deepanshi Thakur
deepanshithakur@translumina.in
9971954733
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2027-11
Participants
Target number of participants: 2000
Related Therapeutic Areas
Sponsors
Collaborators: Iqvia Pty Ltd
Leads: Translumina Therapeutics Pvt Ltd.