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Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Artery Coronary Stenosis

NCT06420505

Translumina GmbH

15 June 2024

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