Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.

Klinikum Arnsberg

Status: Completed

Conditions: Atherosclerotic Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02462005

Ranger SFA Registry

Details and patient eligibility

About

A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon.

Interim analysis will be carried out for every 50 subjects enrolled.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Patient must be willing to sign a a patient informed consent form.
• Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon.
• Target vessel reference diameter 2.5 to 8 mm.

Exclusion criteria

• Subjects pregnant or planning to become pregnant during the course of the study.
• Life expectancy of less than 1 year.
• Known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications. Subject enrolled in another study that has not reached its primary endpoint at the time of enrolment.

Trial design

171 participants in 1 patient group

ALL COMERS

Description:

Patients implanted or scheduled for an implant with a Ranger Drug coated balloon.