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Studies

Observational Recruiting

NCT06412250 on ClinicalTrials.gov

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

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

  • Sponsor: Translumina Therapeutics Pvt Ltd.
  • Collaborators: Iqvia Pty Ltd
  • Enrollment: 2000 (Estimated)
  • Study start: 2024-01-10 (Actual)
  • Primary completion: 2027-07-01 (Estimated)
  • Study completion: 2027-11-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief 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.

Conditions

  • Cardiovascular Diseases

Primary Outcome Measures

  • Ischemic endpoint (12 months)
    Cardiovascular death, myocardial infarction (not clearly attributable to a non-target vessel), definite or probable stent thrombosis or urgent target lesion revascularization (TLR).
  • Bleeding endpoint (12 months)
    bleeding defined as Bleeding Academic Research Consortium (BARC) class 3 or higher

Countries

India, Italy, Netherlands, United Kingdom

Locations and Investigators

  • Zydus Hospitals, Ahmedabad, India (Recruiting)
  • Fortis Hospital, Bangalore, India (Recruiting)
  • Adesh Hospital, Bathinda, India (Recruiting)
  • PGIMER, Chandigarh, India (Recruiting)
  • National Heart Institute, Delhi, India (Recruiting)
  • Fortis Escorts Heart Institute & Research Centre, Delhi, India (Recruiting)
    • Nibedita Biswas
  • Fortis Escorts Heart Institute & Research Centre, Delhi, India (Recruiting)
  • Medanta-The Medicity, Gurugram, India (Recruiting)
  • Yashoda Hospitals, Hyderabad, India (Recruiting)
  • Shalby Hospital, Jabalpur, India (Recruiting)
  • Fortis Hospital, Kalyān, India (Recruiting)
  • L.P.S Institute of Cardiology, Kanpur, India (Recruiting)
    • Anshul
  • Fortis Hospital, Kolkata, India (Recruiting)
  • Dr. Ram Manohar Lohia Hospital (RML), Lucknow, India (Recruiting)
  • Seva Sadan Hospital, Miraj, India (Recruiting)
    • Suhas
  • Fortis, Mohali, India (Recruiting)
  • Yashodha Hospital, Somājigūda, India (Recruiting)
    • Bhawani
  • ASREM - Regional Hospitals, Campobasso, Italy (Recruiting)
  • Montevergine, Mercogliano AV, Italy (Recruiting)
  • Clinica Mediterranea, Napoli, Italy (Recruiting)
  • University of Padua, Padova, Padua, Italy (Recruiting)
  • Clinica Pierangeli, Pescara, Italy (Recruiting)
  • Santo Spirito Hospital, Pescara, Italy (Recruiting)
  • Tor Vergata University, Roma, Italy (Recruiting)
  • Amsterdam UMC (University Medical Centers), Amsterdam, Netherlands (Recruiting)
  • Tergooi MC, Hilversum, Netherlands (Recruiting)
  • Viecuri MC, Venlo, Netherlands (Recruiting)
  • Bedford Hospital, Bedford, United Kingdom (Recruiting)
  • Freeman Hospital, Newcastle, United Kingdom (Recruiting)
  • Derriford Hospitalm Plymouth NHS Trust, Plymouth, United Kingdom (Recruiting)
  • Salisbury NHS Foundation Trust, Salisbury, United Kingdom (Recruiting)
  • Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, United Kingdom (Recruiting)

Study Officials