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

Korábbi kezelés

• 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.
• 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.
• 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.
• 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).
• 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.
• Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained according to guidelines.
• Subject is currently participating or plans to participate in another clinical investigation with an investigational device or an investigational drug.
• Target lesion is excluded if it meets any of the following criteria:
  • Lesion is located within or treated through a saphenous vein graft or arterial graft.
  • Lesion location is within the left main coronary artery.
  • Lesion location is within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX) coronary arteries.
  • Involves a side branch of > 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.
  • Lesion is totally occluded (100% stenosis).
  • 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).
• Target vessel was treated with brachytherapy any time prior to the index procedure.

Más betegség

• 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.
• Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
• 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.

Laborértékek

• 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.

Egyéb

• Subject is hemodynamically unstable.
• Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
• Future planned PCI (including staged procedure) or CABG after the index procedure.
• Subject will refuse blood transfusions.
• Subject has life expectancy of < 1 year.
• In the investigator's opinion, subject will not be able to comply with the follow-up requirements.
  • Angiographic exclusion criteria:
• 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.
• 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.
• Non-target lesion is excluded if it meets any of the following criteria:
  • Any of the target lesion angiographic exclusion criteria except for 1c
  • Lesion is located within the target vessel.
  • Lesion is > 36 mm by operator visual estimate.
  • Lesion requires additional, unplanned stents to treat a complication.
  • 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.)

• 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.
  • Angiographic inclusion criteria:
• 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.
• 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.
• 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).