Status:
RECRUITING
Evaluation of the Vivo Isar Stent System in Routine Clinical Practice
Lead Sponsor:
Translumina GmbH
Collaborating Sponsors:
EVAMED
Conditions:
Artery Coronary Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
The rationale for this observatory is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent System in Real World CAD Patients with follow-up at 12 months....
Eligibility Criteria
Inclusion Criteria:
- ≥18 years old
- Ability to provide signed informed consent form.
- Male or non-pregnant female patient (Pregnancy status to be confirmed verbally from the female patient of reproductive age)
- Presentation with acute coronary syndrome or chronic coronary syndrome with stable angina or angina equivalent symptoms or with a positive noninvasive test for ischemia or evidence of a functionally significant coronary stenosis.
- Patient having social security number.
- Patient treated only with Vivo ISAR stent in case of single or multiple vessel stenting
Exclusion Criteria:
- Concurrent participation in another clinical trial.
- Having benefited from an angioplasty of ≤ 1 month with a stent other than Vivo ISAR.
- Planned elective surgery in next 6 months
- Cardiogenic shock/ hemodynamically unstable patients
- Concurrent medical condition with a life expectancy of less than 12 months
- History of cerebrovascular accident in the last 6 months.
- Vulnerable patient under guardianship or curatorship
Key Trial Info
Start Date :
November 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06420505
Start Date
November 29 2023
End Date
January 1 2027
Last Update
June 6 2024
Active Locations (19)
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1
Clinique Axium
Aix-en-Provence, France, 13100
2
CHU CAEN
Caen, France, 14000
3
Hôpital A. Schweitzer - GHCA
Colmar, France, 68003
4
Clinique Louis Pasteur
Essey-lès-Nancy, France, 54271