Back to resultsEvaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia (ACOART-BTK)
Primary Purpose
Peripheral Artery Disease
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
DEB
PTA
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease
Eligibility 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
Sites / Locations
- Cardiovascular Department, Ospedale S.Donato
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Drug-eluting balloon
conventional PTA
Arm Description
angioplasty with Litos drug-eluting balloon
angioplasty with conventional balloon
Outcomes
Primary Outcome Measures
Late Lumen Loss (LLL) in the target lesion documented by angiography
Late Lumen Loss (LLL) in the target lesion documented by angiography
Secondary Outcome Measures
Number of events of angiographic occlusive restenosis
number of events of angiographic occlusive restenosis
Number of events of target lesion revascularization (TLR)
number of events of target lesion revascularization
Full Information
NCT ID
NCT02563535
First Posted
September 27, 2015
Last Updated
January 17, 2020
Sponsor
Ospedale San Donato
1. Study Identification
Unique Protocol Identification Number
NCT02563535
Brief Title
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
Acronym
ACOART-BTK
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Donato
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug-eluting balloon
Arm Type
Experimental
Arm Description
angioplasty with Litos drug-eluting balloon
Arm Title
conventional PTA
Arm Type
Active Comparator
Arm Description
angioplasty with conventional balloon
Intervention Type
Device
Intervention Name(s)
DEB
Intervention Description
angioplasty with Litos drug eluting balloon
Intervention Type
Device
Intervention Name(s)
PTA
Intervention Description
angioplasty with conventional balloon
Primary Outcome Measure Information:
Title
Late Lumen Loss (LLL) in the target lesion documented by angiography
Description
Late Lumen Loss (LLL) in the target lesion documented by angiography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of events of angiographic occlusive restenosis
Description
number of events of angiographic occlusive restenosis
Time Frame
6 months
Title
Number of events of target lesion revascularization (TLR)
Description
number of events of target lesion revascularization
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cardiovascular Department, Ospedale S.Donato
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
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