Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

Last updated: June 4, 2024
Sponsor: Translumina GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Treatment

Percutaneous Coronary Intervention

Clinical Study ID

NCT06420505
TRANSLUMINA
  • Ages > 18
  • All Genders

Study 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. All medications and procedures to be used/ performed in this observatory are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years old

  • Ability to provide signed informed consent form.

  • Male or non-pregnant female patient (Pregnancy status to be confirmed verbally fromthe female patient of reproductive age)

  • Presentation with acute coronary syndrome or chronic coronary syndrome with stableangina or angina equivalent symptoms or with a positive noninvasive test forischemia 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 vesselstenting

Exclusion

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

Study Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: Percutaneous Coronary Intervention
Phase:
Study Start date:
November 29, 2023
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • Clinique Axium

    Aix-en-Provence, 13100
    France

    Active - Recruiting

  • CHU CAEN

    Caen, 14000
    France

    Site Not Available

  • Hôpital A. Schweitzer - GHCA

    Colmar, 68003
    France

    Active - Recruiting

  • Clinique Louis Pasteur

    Essey-lès-Nancy, 54271
    France

    Active - Recruiting

  • CH Haguenau

    Haguenau, 67500
    France

    Active - Recruiting

  • CHU La Timone

    Marseille, 13005
    France

    Active - Recruiting

  • Hopital Nord

    Marseille, 13015
    France

    Site Not Available

  • HP Jacques Cartier

    Massy, 91300
    France

    Active - Recruiting

  • Clinique Pont de Chaume

    Montauban, 82000
    France

    Site Not Available

  • Hôpital Privé du Confluent

    Nantes, 44277
    France

    Active - Recruiting

  • Polyclinique Les Fleurs

    Ollioules, 83190
    France

    Active - Recruiting

  • APHP

    Paris, 75013
    France

    Site Not Available

  • HP Claude Galien

    Quincy-sous-Sénart, 91480
    France

    Site Not Available

  • CHU Reims

    Reims, 51000
    France

    Active - Recruiting

  • Clinique Saint Hilaire

    Rouen, 76000
    France

    Active - Recruiting

  • CHRU Strasbourg

    Strasbourg, 67091
    France

    Site Not Available

  • CH de Bigorre

    Tarbes, 65013
    France

    Active - Recruiting

  • Chu Toulouse

    Toulouse, 31400
    France

    Active - Recruiting

  • Clinique Pasteur

    Toulouse, 31076
    France

    Site Not Available

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