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Drug Eluting Balloon in peripherAl inTErvention SFA (DEBATE SFA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT01556542
First received: March 13, 2012
Last updated: January 26, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Peripheral Arterial Disease
Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
Device: nitinol stent implantation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study

Resource links provided by NLM:


Further study details as provided by Ospedale San Donato:

Primary Outcome Measures:
  • angiographic binary restenosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    incidence of binary restenosis


Secondary Outcome Measures:
  • major amputation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    incidence of major amputation

  • target lesion revascularization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    incidence of target lesion revascularization

  • vessel reocclusion [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    incidence of vessel reocclusion


Enrollment: 104
Study Start Date: November 2010
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Ospedale San Donato

Additional 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
Study First Received: March 13, 2012
Last Updated: January 26, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale San Donato:
peripheral arterial disease
drug-eluting balloon
restenosis

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

ClinicalTrials.gov processed this record on November 25, 2014