Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)

This study is an non-randomized, prospective, multi-center, non-interventional study (NIS=registry, for Germany: §23b MPG)

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