First in Men Study: BIOMAG-I

Study Overview
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Brief Summary
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A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.

Detailed Description
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Clinical follow-up visits will take place at 1, 6, and 12 months and annually thereafter until 60 months post procedure. All subjects will undergo an angiographic follow-up at 6- and 12-month follow up. IVUS, (including IVUS-VH documentation) and OCT will be performed for all subjects at 6-month and 12-month follow-up (if the safety of the subject allows it and as per the investigator's decision). Vasomotion will be assessed angiographically with Acetylcholine followed by Nitroglycerine at 12 months follow up in a subgroup of subjects, upon the investigators discretion and if subject consents.

Official Title
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BIOTRONIK - Safety and Clinical Performance of the - Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium 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 PCI Subject eligible for PCI Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions and can be covered with 1 device each Reference vessel diameter between 2.5-4.2 mm by visual estimation, depending on the scaffold size used Target lesion length ≤ 28 mm by visual estimation, depending on the scaffold size used Target lesion stenosis by visual estimation > 50% - < 100% and TIMI flow ≥1 (assisted by e.g. QCA / IVUS /FFR). Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients without angiographic evidence of thrombus at target lesion 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. Left main coronary artery disease Three-vessels with coronary artery disease requiring treatment at time of procedure Planned interventional treatment of any non-target vessel within 12-month post-procedure Subjects on dialysis Planned intervention of the target vessel post index procedure Ostial target lesion (within 5.0 mm of vessel origin) Target lesion involves a side branch >2.0 mm in diameter Documented left ventricular ejection fraction (LVEF) ≤ 30% within the last 6 months Heavily calcified lesion Target lesion is located in or supplied by an arterial or venous bypass graft Target lesion requiring treatment with a device other than the non-compliant pre-dilatation balloon or scoring balloon prior to scaffold placement (including but not limited to rotational atherectomy, etc.) Unsuccessful pre-dilatation, defined as a residual stenosis rate more than 20%, estimated by any method and/or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections) Known allergies to: Acetylsalicylic Acid (ASA), P2Y12 inhibitors, Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material Subject is receiving an oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has a known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus) diabetes mellitus is not excluded) A stenosis located proximal or distal to the target lesion that might require future revascularization or an impede run off detected during diagnostic angiography Life expectancy less than 1 year Planned surgery or dental surgical procedure within 6 months after index procedure unless DAPT will be maintained In the investigators opinion, subject will not be able to comply with the follow-up requirements Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet

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: Treatment<br>All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) and followed up until 60 months. | Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold<br>* Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In scaffold late lumen loss | Independent Core Lab Assessment | At 6 months after index procedure |