RecruitingNot ApplicableNCT06779630

Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

A Prospective Multicenter Single Arm Study to Assess the Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System for the Treatment of Subjects With Atherosclerotic Lesion(s)


Sponsor

Teleflex

Enrollment

150 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) \>36 mm and ≤ 44 mm in length (by visual estimate) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm. Patients enrolled in the United States will be followed for 2 years post index procedure with follow-up visits at 1, 6, 12 months and 2 years post index procedure. Patients enrolled outside of the United States will be followed through 5 years post index procedure with additional follow-up visits at 3 and 5 years post index procedure.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System for people with coronary artery disease. The study is currently recruiting participants at 20 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOrsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System

Orsiro Mission is composed of a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.


Locations(23)

John Muir Medical Center

Concord, California, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Barnes Jewish Hospital

St Louis, Missouri, United States

North Shore University Hospital

Manhasset, New York, United States

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, United States

Baylor Scott & White The Heart Hospital - Dallas

Dallas, Texas, United States

Ascension Texas Cardiovascular

Kyle, Texas, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie, Medizinische Universität Wien

Vienna, State of Vienna, Austria

Klinische Abteilung für Kardiologie, Medizinische Universität Graz

Graz, Styria, Austria

Hospices Civils de Lyon - CHU de Lyon

Lyon, Auvergne-Rhône-Alpes, France

Clinique Louis Pasteur

Essey-lès-Nancy, Grand Est, France

Institut Arnault Tzanck

Saint-Laurent-du-Var, Provence-Alpes-Côte d'Azur Region, France

Hôpital Cochin - Groupe AP-HP

Paris, Île-de-France Region, France

Universitätsklinikum Mannheim, I. Medizinische Klinik

Mannheim, Baden-Wurttemberg, Germany

Klinikum Fürth

Fürth, Bavaria, Germany

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Segeberger Kliniken GmbH

Bad Segeberg, Schleswig-Holstein, Germany

Miedziowe Centrum Zdrowia SA

Lubin, Lower Silesian Voivodeship, Poland

University hospital Basel

Basel, Canton of Basel-City, Switzerland

Istituto Cardiocentro Ticino

Lugano, Canton Ticino, Switzerland

View Full Details on ClinicalTrials.gov

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NCT06779630


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