Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation (DEBATE-BTK)

Leonardo Bolognese, MD

Status and phase: Completed; Phase 4

Conditions: Critical Limb Ischemia

Treatments: Device: PEB; Device: POBA

Study type: Interventional

Funder types: Other

Identifiers

NCT01558505

Arezzo005

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 2 patient groups

standard PTA

Active Comparator group

Description:

conventional balloon angioplasty

Treatment:

Device: POBA

Drug-eluting balloon angioplasty

Experimental group

Description:

paclitaxel-eluting balloon angioplasty

Treatment:

Device: PEB