Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

Recruiting

• Conditions: Artery Coronary Stenosis

• Registration Number: NCT06420505
• Lead Sponsor: Translumina GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-29
• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-20
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-06
• Primary Completion: 2026-11-29
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of target lesion failure	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 Outcome Measures

Name	Time	Method
Device success rate	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
Procedural success rate	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
• Evaluate the antiplatelet treatment	12 months post-procedure	antiplatelet consumption during 1 year after the procedure
Assess reperfusion	12 months post-procedure	Target Lesion Revascularization at 12 months

Trial Locations

Locations (19)

CHU CAEN; 🇫🇷 Caen, France

Hôpital A. Schweitzer - GHCA; 🇫🇷 Colmar, France

CHU La Timone; 🇫🇷 Marseille, France

HP Jacques Cartier; 🇫🇷 Massy, France

Clinique Pont de Chaume; 🇫🇷 Montauban, France

Chu Toulouse; 🇫🇷 Toulouse, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Clinique Axium; 🇫🇷 Aix-en-Provence, France

CH Haguenau; 🇫🇷 Haguenau, France

Clinique Louis Pasteur; 🇫🇷 Essey-lès-Nancy, France

Hopital Nord; 🇫🇷 Marseille, France

Hôpital Privé du Confluent; 🇫🇷 Nantes, France

APHP; 🇫🇷 Paris, France

HP Claude Galien; 🇫🇷 Quincy-sous-Sénart, France

Polyclinique Les Fleurs; 🇫🇷 Ollioules, France

CHU Reims; 🇫🇷 Reims, France

Clinique Saint Hilaire; 🇫🇷 Rouen, France

CHRU Strasbourg; 🇫🇷 Strasbourg, France

CH de Bigorre; 🇫🇷 Tarbes, France