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NCT01558505 Clinical Trial

Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation

Critical Limb Ischemia Clinical Trial

— DEBATE-BTK  

Official title:
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01558505
Other study ID # Arezzo005
Secondary ID
Status Completed
Phase Phase 4
First received March 17, 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

Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.

Recruitment information / eligibility
Status Completed
Enrollment 142
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

- 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

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:
• PEB
paclitaxel-eluting balloon angioplasty
• POBA
conventional balloon angioplasty

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 motnhs 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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