Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-29

Study Completion Date

2027-01-01

Brief Summary

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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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Detailed Description

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Conditions

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Artery Coronary Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Percutaneous Coronary Intervention

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No