Randomized Trial of Stenting After Dilation With or Without Paclitaxel Eluting Balloon or Atherectomy in Patients With Symptomatic Peripheral Artery Disease
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Diseases
- Sponsor
- Deutsches Herzzentrum Muenchen
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Percentage diameter stenosis
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Percentage diameter stenosis
Time Frame: 6 months
Secondary Outcomes
- 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)
- 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)