Drug Eluting Balloon in Peripheral Intervention for In-Stent Restenosis (DEBATE-ISR)

Leonardo Bolognese, MD

Status: Suspended

Conditions: Peripheral Arterial Disease

Treatments: Device: POBA; Device: DEB

Study type: Observational

Funder types: Other

Identifiers

NCT01558531

Arezzo006

Details and patient eligibility

About

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.

Enrollment: 44 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, 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

Trial design

44 participants in 2 patient groups

DEB

Description:

paclitaxel-eluting balloon angioplasty

Treatment:

Device: DEB

conventional PTA

Description:

historical conventional balloon angioplasty control group (patients referred to our institution between 2008 and 2009)

Treatment:

Device: POBA