NCT01556542CompletedPhase 4
Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study
Leonardo Bolognese, MD1 site in 1 country104 target enrollmentStarted: November 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- angiographic binary restenosis
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age>18 years
- •intermittent claudication(Fontane III or IV)
- •angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm
- •at least one below-knee vessel to the ankle
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
Arms & Interventions
standard PTA
Active Comparator
nitinol stent implantation
Intervention: nitinol stent implantation (Device)
DEB
Experimental
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
Intervention: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation (Device)
Outcomes
Primary Outcomes
angiographic binary restenosis
Time Frame: 12 months
incidence of binary restenosis
Secondary Outcomes
- major amputation(24 months)
- target lesion revascularization(24 months)
- vessel reocclusion(24 months)
Investigators
Leonardo Bolognese, MD
Director of Cardiovascular Department
Ospedale San Donato
Study Sites (1)
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