NCT06420505RecruitingNot Applicable
Multicenter Observatory Evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System VIVO ISAR in Routine Clinical Practice (CELEBRITY Observatory)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Translumina GmbH
- Enrollment
- 3,000
- Locations
- 19
- Primary Endpoint
- rate of target lesion failure
Study Overview
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. 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Device success rate(12 months post-procedure)
- Procedural success rate(7 days post-procedure)
- • Evaluate the antiplatelet treatment(12 months post-procedure)
- Assess reperfusion(12 months post-procedure)
Investigators
Study Sites (19)
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