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

Part of paid clinical trials in Concord, California.

Sponsor
Teleflex
Study ID
NCT06779630
Status
Recruiting
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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jul 18, 2025
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2031

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System

Primary Outcome Measure

Target Lesion Failure (TLF) rate at 12 months post-index procedure [ Time Frame: 12 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
John Muir Medical CenterConcordCalifornia94520-
Ascension Via Christi Hospitals WichitaWichitaKansas67214-
North Shore University HospitalManhassetNew York11030-
Columbia University Irving Medical Center/New York Presbyterian HospitalNew YorkNew York10032-
Baylor Scott & White The Heart Hospital - DallasDallasTexas75226-
Ascension Texas CardiovascularKyleTexas78640-
Charleston Area Medical CenterCharlestonWest Virginia25304-

Find similar trials in Concord, CA

By research site
John Muir Medical Center· Concord, CAAscension Via Christi Hospitals Wichita· Wichita, KSNorth Shore University Hospital· Manhasset, NYColumbia University Irving Medical Center/New York Presbyterian Hospital· New York, NYBaylor Scott & White The Heart Hospital - Dallas· Dallas, TXAscension Texas Cardiovascular· Kyle, TX

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