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)

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 150 participants

Interventions

• DEVICE: Orsiro 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.

Primary Outcomes

• Target Lesion Failure (TLF) rate at 12 months post-index procedure (12 months)

Secondary Outcomes

• Device success (Hospital Discharge (6-24 hours post-index procedure))
• Procedure success (Hospital Discharge (6-24 hours post-index procedure))
• All-cause death (1, 6, 12 months and 2, 3, and 5 years post-index procedure)
• Any myocardial infarction (MI) (1, 6, 12 months and 2, 3, and 5 years post-index procedure)
• Cardiac death or myocardial infarction (MI) (1, 6, 12 months and 2, 3, and 5 years post-index procedure)

Trial Locations

• John Muir Medical Center, Concord, California, United States
• Ascension Via Christi Hospitals Wichita, Wichita, Kansas, 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
• Klinische Abteilung für Kardiologie, Medizinische Universität Graz, Graz, Styria, Austria
• Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie, Medizinische Universität Wien, Vienna, Vienna, Austria
• Institut Arnault Tzanck, Saint-Laurent-du-Var, Provence-Alpes-Côte d'Azur Region, France
• ...and 7 more locations

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