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

NCT06779630 | Recruiting FDA Device

• 1 other identifier: G240288
• Study Type: interventional
• Target: 150
• Locations: 6 countries
• Sites: 19

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Orsiro Mission; Sirolimus-Eluting; Coronary Stent System; coronary artery disease

Outcome Measures

Primary Outcomes (1)

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

  The primary endpoint will be target lesion failure (TLF) rate at 12 months post-index procedure. TLF is defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR).

  12 months

Secondary Outcomes (11)

• 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

Study Arms (1)

Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System

EXPERIMENTAL

Device: Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System

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.

Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 18 years of age
• Subject is able to understand the nature of the study and provide written informed consent.
• For sites outside of the United States: Note: For subjects presenting with STEMI and not in a position to read, interpret and sign the informed consent form, oral informed consent is required.
• Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines.
• Subject is an acceptable candidate for CABG.
• Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines.
• Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
• Subject is willing and able to comply with study follow-up requirements.
• Subject has only one target lesion in a native coronary artery to be treated with the investigational device.
• Note: One additional non-target lesion may be treated with a non-investigational treatment (e.g. stent, balloon angioplasty, atherectomy) with the exception of brachytherapy, if it is located in a different coronary artery. The non-target lesion must be treated first and must be deemed an angiographic success. (Angiographic success is defined by a residual diameter stenosis \< 30% with TIMI 3 flow, as visually assessed by the physician, without the presence of prolonged chest pain or ECG changes consistent with MI.)
• Note: Multiple focal stenoses will be considered as a single lesion if they are amenable to treatment with a single study device.
• Target lesion must be \> 36 mm and ≤ 44 mm in length by operator visual estimate and must be amenable to treatment with a single study device.
• Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate.
• For sites in United States: Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.
• For sites outside of the United States: Target lesion can be de novo, restenotic or in-stent restenotic, and must be located in a native coronary artery.

You may not qualify if:

• For sites in United States only: Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure.
• Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
• Subject is hemodynamically unstable.
• Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
• Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA or sirolimus.
• Revascularization of any target vessel within 12 months prior to the index procedure or previous PCI of any non-target vessel within \<72 hours prior to the index procedure.
• Future planned PCI (including staged procedure) or CABG after the index procedure.
• Planned surgery or dental surgical procedure within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period.
• History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
• Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
• Subject will refuse blood transfusions.
• Subject has a left ventricular ejection fraction (LVEF) \< 30% within 6 months prior to or during the index procedure that was documented by any method.
• Subject is dialysis dependent or has impaired renal function (i.e., serum creatinine \> 2.5 mg/dL or 221 µmol/L, determined within 7 days prior to the index procedure).
• Subject has a documented white blood cell count \< 3,000 white blood cells/mm3 or a documented platelet count \< 100,000 platelets/mm3 or \> 700,000 platelets/mm3.
• Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted).

Sponsors & Collaborators

• BIOTRONIK AG (A Teleflex Company): collaborator
• Teleflex: lead

Study Sites (19)

John Muir Medical Center

Concord, California, 94520, United States

RECRUITING

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States

RECRUITING

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Baylor Scott & White The Heart Hospital - Dallas

Dallas, Texas, 75226, United States

RECRUITING

Ascension Texas Cardiovascular

Kyle, Texas, 78640, United States

RECRUITING

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

RECRUITING

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

Vienna, State of Vienna, 1090, Austria

RECRUITING

Klinische Abteilung für Kardiologie, Medizinische Universität Graz

Graz, Styria, 8036, Austria

RECRUITING

Clinique Louis Pasteur

Essey-lès-Nancy, Grand Est, 54270, France

RECRUITING

Institut Arnault Tzanck

Saint-Laurent-du-Var, Provence-Alpes-Côte d'Azur Region, 06700, France

RECRUITING

Hôpital Cochin - Groupe AP-HP

Paris, Île-de-France Region, 75014, France

RECRUITING

Universitätsklinikum Mannheim, I. Medizinische Klinik

Mannheim, Baden-Wurttemberg, 68167, Germany

RECRUITING

Klinikum Fürth

Fürth, Bavaria, 90766, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Segeberger Kliniken GmbH

Bad Segeberg, Schleswig-Holstein, 23795, Germany

RECRUITING

Miedziowe Centrum Zdrowia SA

Lubin, Lower Silesian Voivodeship, 59-301, Poland

RECRUITING

University hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

Istituto Cardiocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

BIOFLOW-48 Project Manager

CONTACT

1-866-246-6990; bioflow-48@teleflex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 16, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); DE (4); PL (1); CH (2); FR (3); AU (2)