Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease

Summary

Participation Requirements

Description

This study is a prospective, multi-center 1:1 randomized trial. Patients will be stratified according to lesion length (? 10 cm/ > 10 cm and < 20 cm / > 20 cm and ? 30 cm). Each strata will include approximately 138 patients. The trial is to investigate the safety and efficacy of the Ranger™ Drug Co...

This study is a prospective, multi-center 1:1 randomized trial. Patients will be stratified according to lesion length (? 10 cm/ > 10 cm and < 20 cm / > 20 cm and ? 30 cm). Each strata will include approximately 138 patients. The trial is to investigate the safety and efficacy of the Ranger™ Drug Coated Balloon in comparison to the IN.PACT™ Drug Coated Balloon in patients with symptomatic femoropopliteal artery disease. All enrolled subjects will be followed through to 24 months to assess the incidence of restenosis by ultrasound and major adverse events (MAE). Follow-up visits occur at 1, 6, 12 and 24-month intervals per local standard of care. Telephone follow-up visits will occur at 36, 48 and 60 month. Up to 414 patients will be enrolled at approximately 10-18 sites in Germany for comparison between the following two groups: Treatment with the Ranger™ Paclitaxel Coated Balloon Catheter (Boston Scientific Corporation, Natick, MA, USA) vs. the IN.PACT™ Drug Eluting Balloon (Medtronic Inc., Minneapolis, MI, USA).

Tracking Information