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NCT02563535 Clinical Trial

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

Peripheral Artery Disease Clinical Trial

— ACOART-BTK  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02563535
Other study ID # Arezzo015
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2015
Est. completion date January 2020

Study information
Verified date January 2020
Source Ospedale San Donato
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• DEB
angioplasty with Litos drug eluting balloon
• PTA
angioplasty with conventional balloon

Locations
Country Name City State
Italy Cardiovascular Department, Ospedale S.Donato Arezzo AR

Sponsors (1)
Lead Sponsor Collaborator
Ospedale San Donato

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Late Lumen Loss (LLL) in the target lesion documented by angiography Late Lumen Loss (LLL) in the target lesion documented by angiography 6 months
Secondary Number of events of angiographic occlusive restenosis number of events of angiographic occlusive restenosis 6 months
Secondary Number of events of target lesion revascularization (TLR) number of events of target lesion revascularization 12 months
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