Actively Recruiting
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Led by Teleflex · Updated on 2026-05-04
150
Participants Needed
19
Research Sites
319 weeks
Total Duration
On this page
Sponsors
T
Teleflex
Lead Sponsor
B
BIOTRONIK AG (A Teleflex Company)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Able to understand the study and provide written informed consent (oral consent allowed for some cases outside the US)
- Suitable candidate for percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) according to guidelines
- Eligible for dual antiplatelet therapy (DAPT)
- Clinical evidence of ischemic heart disease, stable or unstable angina, or silent ischemia
- Willing and able to comply with study follow-up
- Has only one target lesion in a native coronary artery suitable for treatment with the study device
- Target lesion length between >36 mm and ≤44 mm
- Target vessel diameter between 2.25 mm and 4.0 mm
- Target lesion with ≥50% and <100% stenosis
- Target vessel with TIMI flow >1
- For US sites: Target lesion must be de novo or restenotic lesion treated only with standard PTCA
- For non-US sites: Target lesion can be de novo, restenotic, or in-stent restenotic
You will not qualify if you...
- For US sites: Acute ST elevation myocardial infarction (STEMI) within 72 hours before procedure
- Hemodynamically unstable
- Pregnant, breastfeeding, or intending pregnancy during study
- Known allergy to contrast medium, certain drugs, or device components
- Revascularization of target vessel within 12 months or non-target vessel PCI within 72 hours before procedure
- Planned PCI or CABG after index procedure
- Planned surgery within 6 months unless DAPT can be maintained
- Stroke or transient ischemic attack within 6 months
- Active bleeding disorders or ineligible for DAPT
- Refusal of blood transfusions
- Left ventricular ejection fraction <30%
- Dialysis dependent or impaired kidney function
- Abnormal white blood cell or platelet counts
- Receiving immunosuppressive therapy or have certain immune diseases
- Receiving or scheduled chemotherapy within 30 days before or after procedure or malignancy not in remission
- On oral anticoagulation therapy unless triple therapy can be maintained
- Life expectancy less than 1 year
- Participating or planning to participate in another investigational study
- Inability to comply with follow-up
- Target lesion in saphenous vein or arterial graft, left main coronary artery, or near origins of LAD or LCX
- Lesions involving side branches requiring two-device strategy
- Totally occluded lesions or restenotic lesions previously treated with bare metal or drug eluting stents (US only)
- Severely tortuous, angulated, or calcified vessels preventing balloon inflation
- Target vessel with thrombus (US only) or unresolved thrombus despite aspiration (non-US)
- Previous brachytherapy on target vessel
- Unsuccessful pre-dilatation or coronary aneurysms (non-US)
- Non-target lesions with certain exclusions such as length over 36 mm, location, or requiring additional stents
- Non-target lesion treatment must be angiographically successful (residual stenosis <30% with TIMI 3 flow)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
John Muir Medical Center
Concord, California, United States, 94520
Actively Recruiting
2
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, United States, 67214
Actively Recruiting
3
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
4
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
5
Baylor Scott & White The Heart Hospital - Dallas
Dallas, Texas, United States, 75226
Actively Recruiting
6
Ascension Texas Cardiovascular
Kyle, Texas, United States, 78640
Actively Recruiting
7
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Actively Recruiting
8
Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie, Medizinische Universität Wien
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
9
Klinische Abteilung für Kardiologie, Medizinische Universität Graz
Graz, Styria, Austria, 8036
Actively Recruiting
10
Clinique Louis Pasteur
Essey-lès-Nancy, Grand Est, France, 54270
Actively Recruiting
11
Institut Arnault Tzanck
Saint-Laurent-du-Var, Provence-Alpes-Côte d'Azur Region, France, 06700
Actively Recruiting
12
Hôpital Cochin - Groupe AP-HP
Paris, Île-de-France Region, France, 75014
Actively Recruiting
13
Universitätsklinikum Mannheim, I. Medizinische Klinik
Mannheim, Baden-Wurttemberg, Germany, 68167
Actively Recruiting
14
Klinikum Fürth
Fürth, Bavaria, Germany, 90766
Actively Recruiting
15
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
16
Segeberger Kliniken GmbH
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Actively Recruiting
17
Miedziowe Centrum Zdrowia SA
Lubin, Lower Silesian Voivodeship, Poland, 59-301
Actively Recruiting
18
University hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031
Actively Recruiting
19
Istituto Cardiocentro Ticino
Lugano, Canton Ticino, Switzerland, 6900
Actively Recruiting
Research Team
B
BIOFLOW-48 Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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