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NCT01556542 Clinical Trial

Drug Eluting Balloon in peripherAl inTErvention SFA

Peripheral Arterial Disease Clinical Trial

— DEBATE SFA  

Official title:
Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date January 2013
Source Ospedale San Donato
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
• nitinol stent implantation
nitinol stent implantation

Locations
Country Name City State
Italy Cardiovascular Department, Ospedale S.Donato Arezzo AR

Sponsors (1)
Lead Sponsor Collaborator
Leonardo Bolognese, MD

Country where clinical trial is conducted

Italy, 

Outcome
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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