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NCT06779630 | NOT YET RECRUITING | Coronary Artery Disease

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

Biotronik, Inc.

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.

Condition or disease

Coronary Artery Disease

Intervention/treatment

Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2027-09
Estimated Study Completion Date : 2031-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Subject is ≥ 18 years of age
  • 2. 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.
  • 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.
  • Angiographic inclusion criteria
    • 1. 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.
    • 2. 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.
    • 3. Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate.
    • 4. 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.
    • 5. Target lesion must have angiographic evidence of ≥ 50% and \< 100% stenosis (by operator visual estimate which may be assisted by QCA / IVUS / OCT). Target lesion stenosis \< 70% should have clinical justification for treatment as per local standards.
    • 6. Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow \> 1.
    • For sites outside of the United States: Note: For STEMI, TIMI flow \> 1 prior to stent implantation (after opening the vessel with a guide wire or a balloon).
    Exclusion Criteria
    • 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.
    • Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
    • 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 on dialysis or impaired renal function (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.
    • Angiographic exclusion criteria
      • 1. Target lesion is excluded if it meets any of the following criteria
        • 1. Lesion is located within or treated through a saphenous vein graft or arterial graft.
        • 2. Lesion location is within the left main coronary artery.
        • 3. Lesion location is within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX) coronary arteries.
        • 4. Involves a side branch of \> 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.
        • 5. Lesion is totally occluded (100% stenosis).
        • 6. For sites in United States only: Lesion is a restenotic lesion that was previously treated with a bare metal or drug eluting stent (in-stent restenosis).
        • 2. Target vessel/lesion is excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.
        • 3. Site sites in the United States: Target vessel has angiographic evidence of thrombus.
        • For sites outside of the United States: Target vessel has angiographic evidence of unresolved large thrombus burden despite of thrombus aspiration.
        • Note: Thrombus aspiration is left at the discretion of the implanting physician.
        • 4. Target vessel was treated with brachytherapy any time prior to the index procedure.
        • 5. Unsuccessful target lesion pre-dilatation, defined as residual stenosis \> 50% (by visual estimation) and/or angiographic complications (e.g., distal embolization, side branch closure, dissection greater than National Heart, Lung, Blood Institute type C), and/or, for sites outside of the United States, coronary aneurysms.
        • 6. Non-target lesion is excluded if it meets any of the following criteria
          • 1. Any of the target lesion angiographic exclusion criteria except for 1c
          • 2. Lesion is located within the target vessel.
          • 3. Lesion is \> 36 mm by operator visual estimate.
          • 4. Lesion requires additional, unplanned stents to treat a complication.
          • 5. Lesion treatment is not 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.)
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions (BIOFLOW-48) Study

Location Details

NCT06779630

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