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Completed

NCT Number: NCT01558505

Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation

Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms 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
  • angiographic stenosis>50% or occlusion of one below-knee vessel

Exclusion criteria

  • allergy to Paclitaxel
  • contraindication for combined antiplatelet treatment
  • life expectancy <1 year
  • hypersensitivity or contraindication to one of the study drugs
  • lack of consent
  • need for amputation

Treatment and study plan

PEB

Device

paclitaxel-eluting balloon angioplasty

POBA

Device

conventional balloon angioplasty

Primary outcomes

  1. angiographic binary restenosis

    Time frame: 12 months

    incidence of binary restenosis

Secondary outcomes

  1. major amputation

    Time frame: 24 motnhs

    incidence of major amputation

  2. target lesion revascularization

    Time frame: 24 months

    incidence of target lesion revascularization

  3. vessel reocclusion

    Time frame: 24 months

    incidence of vessel reocclusion

Sponsors and collaborators

Lead sponsor

Leonardo Bolognese, MD

Other

Registry information

Official study title

Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study

Acronym: DEBATE-BTK

Important dates

Study start
2010
Primary completion
2012
First posted
Mar 20, 2012
Registry last updated
Jan 29, 2013

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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