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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563535
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato

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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: DEB Device: PTA Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2015
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: Drug-eluting balloon
angioplasty with Litos drug-eluting balloon
Device: DEB
angioplasty with Litos drug eluting balloon

Active Comparator: conventional PTA
angioplasty with conventional balloon
Device: PTA
angioplasty with conventional balloon




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


Secondary Outcome Measures :
  1. Number of events of angiographic occlusive restenosis [ Time Frame: 6 months ]
    number of events of angiographic occlusive restenosis

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563535


Locations
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Italy
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100
Sponsors and Collaborators
Ospedale San Donato
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Responsible Party: Leonardo Bolognese, MD, MD, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT02563535    
Other Study ID Numbers: Arezzo015
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases