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NCT Number: NCT06420505

Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

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.

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Key information

Conditions

Artery Coronary Stenosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Axium, Aix-en-Provence, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Device

The Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.

Primary outcomes

  1. rate of target lesion failure

    Time frame: 12 months post-procedure

    • The rate of target lesion failure at 12 months follow-up defined as the composite endpoint of:
    • Cardiac death
    • Myocardial infarction related to the target vessel
    • Clinically documented target lesion revascularization

Secondary outcomes

  1. Device success rate

    Time frame: 12 months post-procedure

    • Device success rate defined as successful placement and deployment of the device at the target lesion site with successful removal of the delivery system leaving a final residual stenosis <30% of the segment of the culprit lesion covered by the stent at 1 year

  2. Procedural success rate

    Time frame: 7 days post-procedure

    • Procedural success rate defined as device success without major ischemia-related adverse cardiac events during hospitalization and up to a maximum of 7 days post-procedure :
    • Cardiac death
    • Any MI
    • Target-vessel MI

  3. Assess reperfusion

    Time frame: 12 months post-procedure

    Target Lesion Revascularization at 12 months

  4. • Evaluate the antiplatelet treatment

    Time frame: 12 months post-procedure

    antiplatelet consumption during 1 year after the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Béatrice GODEFROY

CONTACT

[email protected]

0623822906 ext. +33

Sponsors and collaborators

Lead sponsor

Translumina GmbH

Industry

Collaborators

  • EVAMED

Registry information

Official study title

Multicenter Observatory Evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System VIVO ISAR in Routine Clinical Practice (CELEBRITY Observatory)

Acronym: CELEBRITY

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 20, 2024
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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