Evaluation of the Vivo Isar Stent System in Routine Clinical Practice (CELEBRITY)

Translumina

Status: Enrolling

Conditions: Artery Coronary Stenosis

Treatments: Device: Percutaneous Coronary Intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06420505

TRANSLUMINA

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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