NCT00986752

Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease

Randomized Trial of Stenting After Dilation With or Without Paclitaxel Eluting Balloon or Atherectomy in Patients With Symptomatic Peripheral Artery Disease

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy of stenting after dilation with or without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral artery disease.

Detailed description

The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Despite the initial technical success rate of more than 95% the late clinical failure remains an important concern. Restenosis after PTA occurs in 40-60% within one year. Percutaneous removal of the obstructive material through atherectomy may reduce restenosis rate. So far, data in support of excisional atherectomy derive from registries. Another attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. There is no randomized comparison of this three different interventional strategies. Thus the aim of this study is to evaluate the efficacy of these strategies in terms or reduction of diameter stenosis at follow-up angiogram.

Conditions

• Peripheral Vascular Diseases

Interventions

Type	Name	Description
DEVICE	Stenting (Smart Stent)	Nitinol stent
DEVICE	Stenting after PEB (Smart Stent, Invatec)	Stenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB).
PROCEDURE	Atherectomy (SilverHawk device)	Atherectomy

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2009-09-30
• Last updated: 2014-03-07

Locations

2 sites across 1 country: Germany