Status:
UNKNOWN
Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Peripheral Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Symptomatic ≥ 70% stenosis of the SFA (Rutherford stage 2-6)
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00986752
Start Date
July 1 2009
End Date
March 1 2015
Last Update
March 7 2014
Active Locations (2)
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1
Deutsches Herzzentrum
München, Germany, 80636
2
I. Medizinische Klinik, Klinikum rechts der Isar
München, Germany, 81675