Peripheral Arterial Disease Clinical Trial
— DEBATE SFAOfficial title:
Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study
NCT number | NCT01556542 |
Other study ID # | Arezzo004 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | March 13, 2012 |
Last updated | January 26, 2013 |
Start date | November 2010 |
Verified date | January 2013 |
Source | Ospedale San Donato |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Cardiovascular Department, Ospedale S.Donato | Arezzo | AR |
Lead Sponsor | Collaborator |
---|---|
Leonardo Bolognese, MD |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | angiographic binary restenosis | incidence of binary restenosis | 12 months | No |
Secondary | major amputation | incidence of major amputation | 24 months | No |
Secondary | target lesion revascularization | incidence of target lesion revascularization | 24 months | No |
Secondary | vessel reocclusion | incidence of vessel reocclusion | 24 months | No |
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