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Completed

NCT Number: NCT01556542

Drug Eluting Balloon in peripherAl inTErvention SFA

The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases 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
  • intermittent claudication(Fontane III or IV)
  • angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm
  • at least one below-knee vessel to the ankle

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

Treatment and study plan

paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

Device

paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

nitinol stent implantation

Device

nitinol stent implantation

Primary outcomes

  1. angiographic binary restenosis

    Time frame: 12 months

    incidence of binary restenosis

Secondary outcomes

  1. major amputation

    Time frame: 24 months

    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: the DEBATE SFA Study

Acronym: DEBATE SFA

Important dates

Study start
2010
Primary completion
2012
First posted
Mar 16, 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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