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

B. Braun

Status: Active, not recruiting

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Procedure: drug coated balloon angioplasty; Device: SeQuent® Please OTW Paclitaxel Coated Balloon Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT02460042

AAG-O-H-1309

Details and patient eligibility

About

The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries. It is the intention of this trial to treat suitable target lesions with drug coated balloon (DCB) only.

Full description

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

Enrollment: 960 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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