Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

NCT06420505 | Recruiting

• 1 other identifier: TRANSLUMINA
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 19

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.

Conditions

Artery Coronary Stenosis

Outcome Measures

Primary Outcomes (1)

• rate of target lesion failure

  • 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

  12 months post-procedure

Secondary Outcomes (4)

• Device success rate

  12 months post-procedure

• Procedural success rate

  7 days post-procedure

• Assess reperfusion

  12 months post-procedure

• • Evaluate the antiplatelet treatment

  12 months post-procedure

Interventions

Percutaneous Coronary Intervention DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all-comers population who qualify for percutaneous coronary intervention (consisting of patients with symptomatic coronary artery disease including chronic coronary syndromes (CCS) and ACS) of any gender, ≥ 18 years old

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Translumina GmbH: lead
• EVAMED: collaborator

Study Sites (19)

Clinique Axium

Aix-en-Provence, 13100, France

RECRUITING

CHU CAEN

Caen, 14000, France

NOT YET RECRUITING

Hôpital A. Schweitzer - GHCA

Colmar, 68003, France

RECRUITING

Clinique Louis Pasteur

Essey-lès-Nancy, 54271, France

RECRUITING

CH Haguenau

Haguenau, 67500, France

RECRUITING

CHU La Timone

Marseille, 13005, France

RECRUITING

Hopital Nord

Marseille, 13015, France

NOT YET RECRUITING

HP Jacques Cartier

Massy, 91300, France

RECRUITING

Clinique Pont de Chaume

Montauban, 82000, France

NOT YET RECRUITING

Hôpital Privé du Confluent

Nantes, 44277, France

RECRUITING

Polyclinique Les Fleurs

Ollioules, 83190, France

RECRUITING

APHP

Paris, 75013, France

NOT YET RECRUITING

HP Claude Galien

Quincy-sous-Sénart, 91480, France

NOT YET RECRUITING

CHU Reims

Reims, 51000, France

RECRUITING

Clinique Saint Hilaire

Rouen, 76000, France

RECRUITING

CHRU Strasbourg

Strasbourg, 67091, France

NOT YET RECRUITING

CH de Bigorre

Tarbes, 65013, France

RECRUITING

Clinique Pasteur

Toulouse, 31076, France

NOT YET RECRUITING

Chu Toulouse

Toulouse, 31400, France

RECRUITING

MeSH Terms

Conditions

Coronary Stenosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Thibault Lhermusier, Pr

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Béatrice GODEFROY

CONTACT

0623822906; beatrice.godefroy@translumina.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: November 29, 2023
• Primary Completion (Estimated): November 29, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 6, 2024

Record last verified: 2024-05

Locations

FR (19)