NCT02701543

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

Prospective, Randomized, Multi-Center Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease With the Ranger Paclitaxel Coated PTA Balloon Catheter (Study Arm) Versus the IN.PACT Drug Eluting Balloon (Control Arm)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 414 (actual)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4.

Detailed 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 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).

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Ranger Drug Eluting Balloon	Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
DEVICE	In Pact Drug Eluting Balloon	Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-10-01
• Completion: 2023-12-01
• First posted: 2016-03-08
• Last updated: 2023-12-20

Locations

1 site across 1 country: Germany