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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02563535
• Date of registration: 27/09/2015
• Prospective Registration: No
• Primary sponsor: Ospedale San Donato
• Public title: Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia ACOART-BTK
• Date of first enrolment: September 2015
• Target sample size: 105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02563535
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Italy

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Artery Disease

Intervention(s)

Device: DEB

Device: PTA

Primary Outcome(s)

Late Lumen Loss (LLL) in the target lesion documented by angiography [Time Frame: 6 months]

Secondary Outcome(s)

Number of events of target lesion revascularization (TLR) [Time Frame: 12 months]

Number of events of angiographic occlusive restenosis [Time Frame: 6 months]

Secondary ID(s)

Arezzo015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors