NCT01960647

FREERIDE STUDY, Freeway Paclitaxel Coated Balloon Catheter to Treat Peripheral Artery Disease

Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Eurocor GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this prospective, Randomized, Controlled, Multicentre, Open Study is to investigate the inhibition of restenosis by the Paclitaxel-eluting Percutaneous transluminal angioplasty (PTA) balloon Freeway versus PTA alone in the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous transluminal angioplasty with uncoated balloon
DEVICE	Percutaneous transluminal angioplasty with Paclitaxel balloon

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-09-01
• First posted: 2013-10-10
• Last updated: 2013-10-10

Locations

17 sites across 6 countries: Austria, Colombia, Germany, Hungary, Italy, Spain