Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia (ACOART-BTK)

San Donato Group (GSD)

Status and phase: Completed; Phase 4

Conditions: Peripheral Artery Disease

Treatments: Device: PTA; Device: DEB

Study type: Interventional

Funder types: Other

Identifiers

NCT02563535

Arezzo015

Details and patient eligibility

About

The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age>18 years
• critical limb ischemia (Rutherford class 4-6)
• angiographic stenosis>50% or occlusion of at least one tibial vessel of at least 40mm for which an interventional treatment is scheduled

Exclusion criteria

• need for major amputation known before intervention
• 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: Single Blind

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105 participants in 2 patient groups

Drug-eluting balloon

Experimental group

Description:

angioplasty with Litos drug-eluting balloon

Treatment:

Device: DEB

conventional PTA

Active Comparator group

Description:

angioplasty with conventional balloon

Treatment:

Device: PTA