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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Page 1 of 5 (19 locations)

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