Drug Eluting Balloon in peripherAl inTErvention SFA (DEBATE SFA)

Leonardo Bolognese, MD

Status and phase: Completed; Phase 4

Conditions: Peripheral Arterial Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01556542

Arezzo004

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups

standard PTA

Active Comparator group

Description:

nitinol stent implantation

Treatment:

Device: nitinol stent implantation

DEB

Experimental group

Description:

paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

Treatment:

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