First in Man Trial - BIOSOLVE-I

Study Overview
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Brief Summary
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First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety

Official Title
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BIOTRONIKS-Safety and Clinical Performance Of the First Drug-Eluting Generation Absorbable Metal Stent In Patients With de Novo Lesions in NatiVE Coronary Arteries (BIOSOLVE - I)

Conditions
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de Novo Lesions in Native Coronary Arteries

Intervention / Treatment
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* Device: AMS-3.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is > 18 years and < 80 years of age Written patient informed consent available prior to PCI Patients with stable or unstable angina pectoris or documented silent ischemia Patient eligible for PCI Patient acceptable candidate for coronary artery bypass surgery Exclusion Criteria: Left ventricular ejection fraction of < 30% Presence of a visible thrombus in the target vessel visualized by angiography Lesion and/or way to lesion extremely calcified (e.g. IVUS catheter can not reach/cross the lesion) Patients with three-vessel where all three vessels require treatment Patients with previous CABG in the target vessel(s) Patients with known coronary artery spasm Myocardial infarction (STEMI/NSTEMI) within 4 weeks of the intended treatment. Determination of CKMB and/or troponin T or I is required. Patients with planned major surgery within 12 months after coronary intervention Patients with risk of either acetylsalicylic acid, clopidogrel or Prasugrel cessation Patients under current Phenprocoumon or Cumarine therapy Impaired renal function (serum creatinine > 2.0mg/dl or 177micromol/l, determined within 72 hours prior to intervention) Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment Totally occluded coronary artery (TIMI flow 0) Lesions located within arterial or venous graft Ostial lesions Previous and/or planned brachytherapy of target vessel Target lesion located in left main coronary artery Stroke or TIA < 6 months prior to procedure Patient with signs of a cardiogenic shock Surgeries of any kind within 30 days prior to screening Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated Pregnant and/or breast-feeding females or females who intend to become pregnant Patient currently enrolled in other investigational device or drug trial Patient with expected incompliance to medical (antiplatelet, anticoagulation) therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational device<br> | Device: AMS-3.0<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure |  | 6 and 12 months |