Status:
COMPLETED
Infrapopliteal Drug Eluting Angioplasty Versus Stenting
Lead Sponsor:
University of Patras
Conditions:
Arterial Occlusive Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief Summary
In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a pe...
Detailed Description
Patients programmed to undergo PTA due to angiographically-proven infrapopliteal arterial disease in our department will be randomized in the above mentioned study arms. The studies primary endpoint w...
Eligibility Criteria
Inclusion
- Angiographically documented infrapopliteal disease.
- Rutherford category of peripheral arterial disease between class 3 to 6
- Lesion length between 70 to 220 mm
- Lesions situated in the proximal, mid and mid to distal segments of the tibial vessels.
Exclusion
- Lesion length \< 70 mm or \> 220 mm.
- Lesions situated in the distal third of the tibial vessels
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01517997
Start Date
August 1 2011
End Date
September 1 2013
Last Update
October 9 2013
Active Locations (1)
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1
Patras University Hospital
Rio, Achaia, Greece, 26500