Safety and Clinical Performance of a Sirolimus-eluting Absorbable Metal Scaffold

Study Overview
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Brief Summary
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Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo coronary artery lesions.

Detailed Description
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This is a prospective, multi-centre, single-arm, open label trial to assess the safety and clinical performance of Magmaris Drug Eluting Absorbable Metal Scaffold. A total of up to 110 patients with de novo lesions in native coronary arteries will be enrolled at up to 8 investigational sites in India. In-hospital clinical follow-up visits will take place at 1 and 6 months post procedure. The primary endpoint is target lesion failure (a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction, coronary artery bypass grafting, clinically driven target lesion revascularization) at 1 month post procedure.

Official Title
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BIOTRONIK - Safety and Clinical Performance Of the Magmaris Drug Eluting Absorbable Metal Scaffold in a Cohort of Patients in India With de Novo Lesions in NatiVE Coronary Arteries

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Bioresorbable scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years and ≤ 80 years of age Written subject informed consent available prior to percutaneous coronary intervention (PCI). Remark: Vulnerable subjects may not be enrolled in this trial Subject with stable or unstable angina pectoris or documented silent ischemia Subject eligible for PCI Subject acceptable candidate for coronary artery bypass surgery Subject with a maximum of two single de novo lesions in two different major epicardial vessels Reference vessel diameter between 2.7-3.7 mm by visual estimation, depending on the scaffold size used Target lesion length ≤ 21 mm by visual estimation, depending on the scaffold size used Target lesion stenosis by visual estimation ≥ 50% - < 100% and TIMI flow ≥1 Eligible for Dual Anti Platelet Therapy (DAPT) Exclusion Criteria: Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study 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 Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the index procedure Left main coronary artery disease Three-vessel coronary artery disease at time of procedure Thrombus in target vessel Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet Planned interventional treatment of any non-target vessel within 30 days post-procedure Subject is on dialysis Planned intervention of the target vessel after the index procedure Ostial target lesion (within 3.0 mm of vessel origin) Target lesion involves a side branch >2.0 mm in diameter Documented left ventricular ejection fraction (LVEF) ≤ 30% Heavily calcified lesion Target lesion is located in or supplied by an arterial or venous bypass graft The target lesion requires treatment with a device other than the pre-dilatation balloon prior to the Magmaris study device placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.) Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of the Magmaris study device and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections that can't be covered by a single scaffold), by visual estimation Known allergies to: Acetylsalicylic Acid (ASA), Heparin, contrast medium, Sirolimus, Everolimus or similar drugs (i.e., ABT 578, Biolimus, Tacrolimus), PLLA, Silicon Carbide, Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum Impaired renal function (serum creatinine > 2.5 mg/dl or 221 µmol/l) determined within 72 hours prior to index procedure Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are not excluded) or has known life limiting immunosuppressive or autoimmune disease (e.g.,human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus) Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography Life expectancy less than 6 months Planned surgery or dental surgical procedure within 6 months after index procedure Subject with tortuous vessel that may impair scaffold placement in the region of obstruction or proximal to the lesion In the investigators opinion subjects will not be able to comply with the follow-up requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioresorbable scaffold<br>Percutaneous coronary intervention (PCI) with a sirolimus-eluting resorbable coronary magnesium scaffold | Device: Bioresorbable scaffold<br>* Percutaneous coronary intervention (PCI)<br>* Other names: Magmaris;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | TLF is a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), coronary artery bypass graft (CABG), clinically driven target lesion revascularization (TLR) | 1 month post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure (TLF) | TLF is a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), coronary artery bypass graft (CABG), clinically driven target lesion revascularization (TLR) | 6 months post-procedure | 
| Target vessel failure (TVF) | TVF is a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), coronary artery bypass graft (CABG), clinically driven target vessel revascularization (TVR) | 1 and 6 months post-procedure | 
| Clinically driven target lesion revascularization |  | 1 and 6 months post-procedure | 
| Cardiac death |  | 1 and 6 months post-procedure | 
| Myocardial infarction |  | 1 and 6 months post-procedure | 
| Scaffold thrombosis | Scaffold thrombosis is composite of definite and probable scaffold thrombosis according to ARC definition | 1 and 6 months post-procedure | 
| Incidence of procedure success | Procedure Success is a composite of achievement of a final diameter stenosis of <30% by visual assessment or on-line quantitative coronary angiography, without the occurrence of death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay (3 days plus or minus 2 days) | 3 days (plus or minus 2 days) | 
| Incidence of device success | Device Success is a composite of a final residual diameter stenosis of <30% by visual assessment or on-line quantitative coronary angiography, using the assigned device only, successful delivery of the scaffold to the target lesion site in the coronary artery, appropriate scaffold deployment, successful removal of the device, safe removal of the device in case of deployment failure. | Participants will be followed for the duration of index procedure, an expected average of 1 hour. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioresorbable scaffold, vascular restoration therapy