NCT01938872
Unknown
Not Applicable
Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia
ConditionsCritical Limb Ischemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critical Limb Ischemia
- Sponsor
- Ospedale San Donato
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- angiographic binary restenosis
- Last Updated
- 12 years ago
Overview
Brief Summary
to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months
Investigators
Leonardo Bolognese, MD
Director
Ospedale San Donato
Eligibility Criteria
Inclusion Criteria
- •age\>18 years
- •angiographic stenosis\>50% or occlusion of one below-knee vessel
Exclusion Criteria
- •allergy to Paclitaxel
- •contraindication for combined antiplatelet treatment
- •life expectancy \<1 year
- •hypersensitivity or contraindication to one of the study drugs
- •lack of consent
- •need for amputation
Outcomes
Primary Outcomes
angiographic binary restenosis
Time Frame: 12 months
incidence of binary restenosis
Study Sites (1)
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