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

Официальное название

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)

Обзор

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.

Вмешательства

• Устройство Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System
  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.

Первичные конечные точки

• Target Lesion Failure (TLF) rate at 12 months post-index procedure [Срок оценки: 12 months]

Вторичные конечные точки (11)

• Device success [Срок оценки: Hospital Discharge (6-24 hours post-index procedure)]
• Procedure success [Срок оценки: Hospital Discharge (6-24 hours post-index procedure)]
• All-cause death [Срок оценки: 1, 6, 12 months and 2, 3, and 5 years post-index procedure]
• Any myocardial infarction (MI) [Срок оценки: 1, 6, 12 months and 2, 3, and 5 years post-index procedure]
• Cardiac death or myocardial infarction (MI) [Срок оценки: 1, 6, 12 months and 2, 3, and 5 years post-index procedure]
• Major cardiac adverse events (MACE) and individual MACE components [Срок оценки: 1, 6, 12 months and 2, 3, and 5 years post-index procedure]
• Target lesion failure (TLF) and individual TLF components [Срок оценки: 1, 6, 12 months and 2, 3, and 5 years post-index procedure]
• Target vessel failure (TVF) and individual TVF components [Срок оценки: 1, 6, 12 months and 2, 3, and 5 years post-index procedure]
• Target lesion revascularization (TLR) [Срок оценки: 1, 6, 12 months and 2, 3, and 5 years post-index procedure]
• Target vessel revascularization (TVR) [Срок оценки: 1, 6, 12 months and 2, 3, and 5 years post-index procedure]
• Stent thrombosis [Срок оценки: 1, 6, 12 months and 2, 3, and 5 years post-index procedure]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).
• 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 has life expectancy of < 1 year.
• Subject is currently participating or plans to participate in another clinical investigation with an investigational device or an investigational drug.
• In the investigator's opinion, subject will not be able to comply with the follow-up requirements.

Angiographic exclusion criteria:

• 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/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.

• Target vessel was treated with brachytherapy any time prior to the index procedure.
• 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.
• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 10 центров

• John Muir Medical Center — Concord
• Ascension Via Christi Hospitals Wichita — Wichita
• Massachusetts General Hospital — Boston
• Henry Ford Hospital — Detroit
• Barnes Jewish Hospital — St Louis
• North Shore University Hospital — Manhasset
• Columbia University Irving Medical Center/New York Presbyterian Hospital — New York
• Baylor Scott & White The Heart Hospital - Dallas — Dallas
• … и ещё 2 центра

Франция · 4 центра

• Hospices Civils de Lyon - CHU de Lyon — Lyon
• Clinique Louis Pasteur — Essey-lès-Nancy
• Institut Arnault Tzanck — Saint-Laurent-du-Var
• Hôpital Cochin - Groupe AP-HP — Paris

Германия · 4 центра

• Universitätsklinikum Mannheim, I. Medizinische Klinik — Mannheim
• Klinikum Fürth — Fürth
• Universitätsklinikum Würzburg — Würzburg
• Segeberger Kliniken GmbH — Bad Segeberg

Австрия · 2 центра

• Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie, Medizinisch — Vienna
• Klinische Abteilung für Kardiologie, Medizinische Universität Graz — Graz

Швейцария · 2 центра

• University hospital Basel — Basel
• Istituto Cardiocentro Ticino — Lugano

Польша · 1 центр

• Miedziowe Centrum Zdrowia SA — Lubin

Идентификаторы

NCT: NCT06779630 · G240288

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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