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

Phase 4

• Conditions: Peripheral Vascular Diseases
• Interventions: Procedure: Atherectomy (SilverHawk device); Device: Stenting (Smart Stent); Device: Stenting after PEB (Smart Stent, Invatec)

• Registration Number: NCT00986752
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief 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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Status Verified: 2010-01
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07
• Primary Completion: 2014-12
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Symptomatic ≥ 70% stenosis of the SFA (Rutherford stage 2-6)
• Written informed consent

Exclusion Criteria

• Acute ischemia and/or acute thrombosis of the SFA
• Untreated ipsilateral iliac artery stenosis >70%
• Previous stenting of the SFA
• Popliteal stenosis >70%
• Severe renal insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atherectomy	Atherectomy (SilverHawk device)	The third randomization arm is Atherectomy.
Stenting	Stenting (Smart Stent)	Due to randomization one nitinol stent will be implanted after dilation with a conventional balloon.
Stenting after PEB	Stenting (Smart Stent)	Due to randomization one nitinol stent will be implanted after dilation with a Paclitaxel eluting balloon.
Stenting after PEB	Stenting after PEB (Smart Stent, Invatec)	Due to randomization one nitinol stent will be implanted after dilation with a Paclitaxel eluting balloon.

Primary Outcome Measures

Name	Time	Method
Percentage diameter stenosis	6 months

Secondary Outcome Measures

Name	Time	Method
Percentage diameter stenosis in duplex ultrasound	6 and 24 months
Change from baseline in functional status and health related quality of life (Walking Impairment Questionaire)	3 and 6 months
All-cause mortality	6 and 24 months
Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)	6 months
Time to onset of any of MAPE.	3-24 months
Binary restenosis rate	6 months

Trial Locations

Locations (2)

Deutsches Herzzentrum; 🇩🇪 Muenchen, Germany

I. Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Muenchen, Germany