Clinical Trial

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

Study acronym: BIOFLOW-48
Recruiting
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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.
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2025-01-14; most recent amendment 2026-07-23.
Status change: Not Yet Recruiting → Recruiting 2025-07-22
Trial Details
NCT Number NCT06779630
Lead Sponsor Teleflex
Collaborators: BIOTRONIK AG (A Teleflex Company)
Conditions Coronary Artery Disease
Enrollment 150 participants
Start Date 2025-07-18
Primary Completion 2027-09 (estimated)
Study Completion 2031-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-24