Actively Recruiting
A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
Led by Translumina Therapeutics Pvt Ltd. · Updated on 2025-09-18
2000
Participants Needed
32
Research Sites
198 weeks
Total Duration
On this page
Sponsors
T
Translumina Therapeutics Pvt Ltd.
Lead Sponsor
I
IQVIA Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written informed consent.
- Treated only with the VIVO ISAR stent system.
- 18 years old or older.
- Male or non-pregnant female patient.
- Intended for treatment with 3 months or less dual antiplatelet therapy after PCI as per standard of care.
You will not qualify if you...
- Concurrent participation in an interventional study.
- Cardiogenic shock or 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 known hypersensitivity to planned antiplatelet 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Zydus Hospitals
Ahmedabad, India, 380054
Actively Recruiting
2
Fortis Hospital
Bangalore, India, 560076
Actively Recruiting
3
Adesh Hospital
Bathinda, India, 151001
Actively Recruiting
4
PGIMER
Chandigarh, India, 160012
Actively Recruiting
5
National Heart Institute
Delhi, India, 11 00 65
Actively Recruiting
6
Fortis Escorts Heart Institute & Research Centre
Delhi, India, 110025
Actively Recruiting
7
Fortis Escorts Heart Institute & Research Centre
Delhi, India, 110025
Actively Recruiting
8
Medanta-The Medicity
Gurugram, India, 122001
Actively Recruiting
9
Yashoda Hospitals
Hyderabad, India, 500081
Actively Recruiting
10
Shalby Hospital
Jabalpur, India, 482002
Actively Recruiting
11
Fortis Hospital
Kalyān, India, 421301
Actively Recruiting
12
L.P.S Institute of Cardiology
Kanpur, India, 208019
Actively Recruiting
13
Fortis Hospital
Kolkata, India, 700107
Actively Recruiting
14
Dr. Ram Manohar Lohia Hospital (RML)
Lucknow, India, 226010
Actively Recruiting
15
Seva Sadan Hospital
Miraj, India, 416410
Actively Recruiting
16
Fortis
Mohali, India, 160062
Actively Recruiting
17
Yashodha Hospital
Somājigūda, India, 500082
Actively Recruiting
18
ASREM - Regional Hospitals
Campobasso, Italy, 86100
Actively Recruiting
19
Montevergine
Mercogliano AV, Italy, 83013
Actively Recruiting
20
Clinica Mediterranea
Naples, Italy, 80122
Actively Recruiting
21
University of Padua, Padova
Padova, Italy, 35122
Actively Recruiting
22
Clinica Pierangeli
Pescara, Italy, 65124
Actively Recruiting
23
Santo Spirito Hospital
Pescara, Italy, 65124
Actively Recruiting
24
Tor Vergata University
Roma, Italy, 00133
Actively Recruiting
25
Amsterdam UMC (University Medical Centers)
Amsterdam, Netherlands, 91105
Actively Recruiting
26
Tergooi MC
Hilversum, Netherlands, 1213 XZ
Actively Recruiting
27
Viecuri MC
Venlo, Netherlands, 5912
Actively Recruiting
28
Bedford Hospital
Bedford, United Kingdom, MK42 9DJ
Actively Recruiting
29
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Actively Recruiting
30
Derriford Hospitalm Plymouth NHS Trust
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
31
Salisbury NHS Foundation Trust
Salisbury, United Kingdom, SP2 8BJ
Actively Recruiting
32
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan, United Kingdom, WN1 2NN
Actively Recruiting
Research Team
D
Diptendu Chatterjee
CONTACT
D
Deepanshi Thakur
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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