Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 13, 2012
January 26, 2013
November 2010
September 2012   (final data collection date for primary outcome measure)
angiographic binary restenosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
incidence of binary restenosis
angiographic binary restenosis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
incidence of binary restenosis
Complete list of historical versions of study NCT01556542 on ClinicalTrials.gov Archive Site
  • 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
  • major amputation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    incidence of major amputation
  • stent thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    incidence of stent thrombosis
  • target lesion revascularization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    incidence of target lesion revascularization
Not Provided
Not Provided
 
Drug Eluting Balloon in peripherAl inTErvention SFA
Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Arterial Disease
  • Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
    paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
  • Device: nitinol stent implantation
    nitinol stent implantation
  • Active Comparator: standard PTA
    nitinol stent implantation
    Intervention: Device: nitinol stent implantation
  • Experimental: DEB
    paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
    Intervention: Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
Liistro F, Grotti S, Porto I, Angioli P, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302. doi: 10.1016/j.jcin.2013.07.010. Epub 2013 Nov 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
Not Provided
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01556542
Arezzo004
No
Leonardo Bolognese, MD, Ospedale San Donato
Leonardo Bolognese, MD
Not Provided
Principal Investigator: Francesco Liistro, MD Cardiovascular Department, San Donato Hospital, Arezzo, Italy
Ospedale San Donato
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP