RECRUITING

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

Conditions

Coronary Artery Disease Orsiro Mission Sirolimus-Eluting Coronary Stent System

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

BIOTRONIK - 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)

Quick Facts

Study Start:2025-07-18

Study Completion:2031-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06779630

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is ≥ 18 years of age 2. Subject is able to understand the nature of the study and provide written informed consent. 3. Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines. 4. Subject is an acceptable candidate for CABG. 5. Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines. 6. Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia. 7. Subject is willing and able to comply with study follow-up requirements.	1. 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. 2. Subject is hemodynamically unstable. 3. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study. 4. 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. 5. 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. 6. Future planned PCI (including staged procedure) or CABG after the index procedure. 7. Planned surgery or dental surgical procedure within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period. 8. History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure. 9. Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT. 10. Subject will refuse blood transfusions. 11. 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. 12. 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). 13. 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. 14. 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). 15. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure or has a malignancy that is not in remission. 16. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained according to guidelines. 17. Subject has life expectancy of \< 1 year. 18. Subject is currently participating or plans to participate in another clinical investigation with an investigational device or an investigational drug. 19. In the investigator's opinion, subject will not be able to comply with the follow-up requirements.

Inclusion Criteria

Exclusion Criteria

1. Subject is ≥ 18 years of age
2. Subject is able to understand the nature of the study and provide written informed consent.
3. Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines.
4. Subject is an acceptable candidate for CABG.
5. Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines.
6. Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
7. Subject is willing and able to comply with study follow-up requirements.

1. 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.
2. Subject is hemodynamically unstable.
3. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
4. 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.
5. 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.
6. Future planned PCI (including staged procedure) or CABG after the index procedure.
7. Planned surgery or dental surgical procedure within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period.
8. History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
9. Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
10. Subject will refuse blood transfusions.
11. 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.
12. 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).
13. 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.
14. 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).
15. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure or has a malignancy that is not in remission.
16. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained according to guidelines.
17. Subject has life expectancy of \< 1 year.
18. Subject is currently participating or plans to participate in another clinical investigation with an investigational device or an investigational drug.
19. In the investigator's opinion, subject will not be able to comply with the follow-up requirements.

Contacts and Locations

Study Contact

BIOFLOW-48 Project Manager

CONTACT

800-547-0394

BIOFLOW-48@biotronik.com

Study Locations (Sites)

Charleston Area Medical Center

Charleston, West Virginia, 25304

United States

Collaborators and Investigators

Sponsor: Biotronik, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-18

Study Completion Date2031-09

Study Record Updates

Study Start Date2025-07-18

Study Completion Date2031-09

Terms related to this study

Keywords Provided by Researchers

Orsiro Mission
Sirolimus-Eluting
Coronary Stent System
coronary artery disease

Additional Relevant MeSH Terms

Coronary Artery Disease