First in Man Trial - BIOSOLVE-I

Biotronik

Status

Completed

Conditions

de Novo Lesions in Native Coronary Arteries

Treatments

Device: AMS-3.0

Study type

Interventional

Funder types

Industry

Identifiers

NCT01168830

C1007

Details and patient eligibility

About

First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety

Enrollment

46 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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