Peripheral Arterial Disease Clinical Trial
— DEBATE-ISROfficial title:
Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study
NCT number | NCT01558531 |
Other study ID # | Arezzo006 |
Secondary ID | |
Status | Suspended |
Phase | Phase 4 |
First received | March 17, 2012 |
Last updated | February 2, 2015 |
Start date | January 2010 |
Verified date | February 2015 |
Source | Ospedale San Donato |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.
Status | Suspended |
Enrollment | 44 |
Est. completion date | |
Est. primary completion date | December 2011 |
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, previously treated with nitinol stent implantation, with 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 - need for amputation - angiographic evidence of stent fracture |
Observational Model: Case Control, Time Perspective: Prospective
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 re-restenosis | incidence of angiographic binary re-restenosis | 12 months | No |
Secondary | major amputation | incidence of major amputation | 24 months | No |
Secondary | stent thrombosis | incidence of stent thrombosis | 24 months | No |
Secondary | target lesion revascularization | incidence of target lesion revascularization | 24 months | No |
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