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Completed

NCT Number: NCT02563535

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

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DEB

Device

angioplasty with Litos drug eluting balloon

PTA

Device

angioplasty with conventional balloon

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ospedale San Donato

Other

Registry information

Acronym: ACOART-BTK

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2015
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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