Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease (ISAR-STATH)

German Heart Center Munich

Status and phase: Unknown; Phase 4

Conditions: Peripheral Vascular Diseases

Treatments: Procedure: Atherectomy (SilverHawk device); Device: Stenting (Smart Stent); Device: Stenting after PEB (Smart Stent, Invatec)

Study type: Interventional

Funder types: Other

Identifiers

NCT00986752

GE IDE No. B00101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Stenting

Active Comparator group

Description:

Due to randomization one nitinol stent will be implanted after dilation with a conventional balloon.

Treatment:

Device: Stenting (Smart Stent)

Stenting after PEB

Experimental group

Description:

Due to randomization one nitinol stent will be implanted after dilation with a Paclitaxel eluting balloon.

Treatment:

Device: Stenting after PEB (Smart Stent, Invatec)

Device: Stenting (Smart Stent)

Atherectomy

Experimental group

Description:

The third randomization arm is Atherectomy.

Treatment:

Procedure: Atherectomy (SilverHawk device)