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Drug Eluting Balloon in peripherAl inTErvention SFA (DEBATE SFA)

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ClinicalTrials.gov Identifier: NCT01556542
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : January 29, 2013
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation Device: nitinol stent implantation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study
Study Start Date : November 2010
Actual Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: standard PTA
nitinol stent implantation
Device: nitinol stent implantation
nitinol stent implantation
Experimental: DEB
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation



Primary Outcome Measures :
  1. angiographic binary restenosis [ Time Frame: 12 months ]
    incidence of binary restenosis


Secondary Outcome Measures :
  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



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

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

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): NCT01556542


Locations
Italy
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100
Sponsors and Collaborators
Leonardo Bolognese, MD
Investigators
Principal Investigator: Francesco Liistro, MD Cardiovascular Department, San Donato Hospital, Arezzo, Italy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leonardo Bolognese, MD, Director of Cardiovascular Department, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01556542     History of Changes
Other Study ID Numbers: Arezzo004
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by Leonardo Bolognese, MD, Ospedale San Donato:
peripheral arterial disease
drug-eluting balloon
restenosis

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action