NCT01969630

Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Ospedale San Donato · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	PEB	Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation
DEVICE	PES	Systematic Paclitaxel eluting stent angioplasty

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-10-01
• First posted: 2013-10-25
• Last updated: 2013-10-25

Locations

1 site across 1 country: Italy