de Novo Lesions in Native Coronary Arteries
Conditions
Brief summary
First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
Interventions
DEVICEAMS-3.0
Sponsors
Biotronik AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure | 6 and 12 months |
Countries
Belgium, Germany, Netherlands, Switzerland
Outcome results
None listed