Clinical Research Directory

Inclusion Criteria (patient): * Willingness to treat the target lesion according to the DCB only concept * Patients in Rutherford classes 2 through 5 * Patients eligible for peripheral revascularization by means of Percutaneous Transluminal Angioplasty (PTA) * Patients must be 18 years of age * Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol * Patients must agree to undergo at least the 12-month clinical follow-up * Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of the paclitaxel-eluting PTA-balloon catheter or other suitable devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document. Inclusion Criteria (lesion): * Peripheral lesions in peripheral arteries above and below the knee with reference vessel diameters between 1.5 and 8.0 mm, lesion lengths ≥ 2 cm and ≤ 27 cm as angiographically documented\* * Diameter stenosis pre-procedure must be 70% * Target lesion above and below the knee * Vessels must have adequate runoff with at least one vessel to the foot. \*Lesions separated by less than 2 cm are considered as one lesion Exclusion Criteria (all comers): * Patient not suitable for revascularization by interventional means