A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
NCT ID: NCT06412250
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2024-01-10
2027-11-30
Brief Summary
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Detailed Description
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All medications and procedures to be used/ performed in this registry are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.
The study does not influence the choice of device utilized nor does it alter the routine standard of care. After a patient has been treated with the Vivo ISAR, informed consent will be requested and the eligible patient will be registered in the study.
Baseline data will be completed using medical notes. All recruited subjects will then be followed as per routine practice together with telephonic follow-up at 30 days, 3 months and 12 months from the baseline PCI procedure date.
The 30 day, 3 months and 12 month telephonic follow up will consist of a verbally report of the DAPT anticoagulation medications continued, about any lab assessments that might have happened, recording of any adverse events, and any interventional treatment that has occurred since previous contact.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Treated only with the VIVO ISAR stent system.
3. ≥ 18 years old.
4. Male or non-pregnant female patient.
5. Intended for treatment with ≤ 3 months DAPT after PCI as per standard of care.
Exclusion Criteria
2. Cardiogenic shock/hemodynamic instability around the time of the index procedure.
3. Concurrent medical condition with a life expectancy of less than 12 months.
4. Allergy or contraindication to antiplatelet therapy, cobalt chromium, sirolimus or any known hypersensitivity to the planned anti-platelet drugs.
5. History of cerebrovascular accident in the last 6 months.
6. Pregnant female.
7. PCI performed within the previous 3 months from the date of index procedure
8. Treated with another stent type during the index procedure in addition to the VIVO ISAR stent system
18 Years
ALL
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
Translumina Therapeutics Pvt Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Prof Adnan Kastrati
Role: STUDY_CHAIR
German Heart Centre Munich, Germany
Prof Azfar Zaman
Role: PRINCIPAL_INVESTIGATOR
Freeman Hospital, Newcastle, UK
Locations
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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
Napoli, , Italy
University of Padua, Padova
Padua, , 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TL/SECURE/VIVO/2023-01
Identifier Type: -
Identifier Source: org_study_id
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