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
1 other identifier
observational
2,000
4 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Typical duration for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2024
CompletedFirst Submitted
Initial submission to the registry
May 8, 2024
CompletedFirst Posted
Study publicly available on registry
May 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
September 18, 2025
September 1, 2025
3.5 years
May 8, 2024
September 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Ischemic endpoint
Cardiovascular death, myocardial infarction (not clearly attributable to a non-target vessel), definite or probable stent thrombosis or urgent target lesion revascularization (TLR).
12 months
Bleeding endpoint
bleeding defined as Bleeding Academic Research Consortium (BARC) class 3 or higher
12 months
Secondary Outcomes (9)
All-cause mortality
12 months
Cardiovascular death
12 months
Myocardial infarction (MI)
12 months
Stroke
12 months
Stent thrombosis (definite/probable)
12 months
- +4 more secondary outcomes
Eligibility Criteria
A real-world population undergoing percutaneous coronary intervention with VIVO-ISAR (Polymer Free Sirolimus Eluting Coronary Stent) and intended for treatment with ≤ 3 months of DAPT
You may qualify if:
- 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.
You may not qualify if:
- Patients having any of the following conditions will not be considered (enrolled) for the study Concurrent participation in an interventional study.
- Cardiogenic shock/hemodynamic instability around the time of the index procedure.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Allergy or contraindication to antiplatelet therapy, cobalt chromium, sirolimus or any known hypersensitivity to the planned anti-platelet drugs.
- History of cerebrovascular accident in the last 6 months.
- Pregnant female.
- PCI performed within the previous 3 months from the date of index procedure
- Treated with another stent type during the index procedure in addition to the VIVO ISAR stent system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Translumina Therapeutics Pvt Ltd.lead
- Iqvia Pty Ltdcollaborator
Study Sites (32)
Zydus Hospitals
Ahmedabad, 380054, India
Fortis Hospital
Bangalore, 560076, India
Adesh Hospital
Bathinda, 151001, India
PGIMER
Chandigarh, 160012, India
National Heart Institute
Delhi, 11 00 65, India
Fortis Escorts Heart Institute & Research Centre
Delhi, 110025, India
Fortis Escorts Heart Institute & Research Centre
Delhi, 110025, India
Medanta-The Medicity
Gurugram, 122001, India
Yashoda Hospitals
Hyderabad, 500081, India
Shalby Hospital
Jabalpur, 482002, India
Fortis Hospital
Kalyān, 421301, India
L.P.S Institute of Cardiology
Kanpur, 208019, India
Fortis Hospital
Kolkata, 700107, India
Dr. Ram Manohar Lohia Hospital (RML)
Lucknow, 226010, India
Seva Sadan Hospital
Miraj, 416410, India
Fortis
Mohali, 160062, India
Yashodha Hospital
Somājigūda, 500082, India
ASREM - Regional Hospitals
Campobasso, 86100, Italy
Montevergine
Mercogliano AV, 83013, Italy
Clinica Mediterranea
Napoli, 80122, Italy
University of Padua, Padova
Padua, 35122, Italy
Clinica Pierangeli
Pescara, 65124, Italy
Santo Spirito Hospital
Pescara, 65124, Italy
Tor Vergata University
Roma, 00133, Italy
Amsterdam UMC (University Medical Centers)
Amsterdam, 91105, Netherlands
Tergooi MC
Hilversum, 1213 XZ, Netherlands
Viecuri MC
Venlo, 5912, Netherlands
Bedford Hospital
Bedford, MK42 9DJ, United Kingdom
Freeman Hospital
Newcastle, NE7 7DN, United Kingdom
Derriford Hospitalm Plymouth NHS Trust
Plymouth, PL6 8DH, United Kingdom
Salisbury NHS Foundation Trust
Salisbury, SP2 8BJ, United Kingdom
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan, WN1 2NN, United Kingdom
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Prof Adnan Kastrati
German Heart Centre Munich, Germany
- PRINCIPAL INVESTIGATOR
Prof Azfar Zaman
Freeman Hospital, Newcastle, UK
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2024
First Posted
May 14, 2024
Study Start
January 10, 2024
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share