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Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01969630
Recruitment Status : Unknown
Verified October 2013 by Leonardo Bolognese, MD, Ospedale San Donato.
Recruitment status was:  Recruiting
First Posted : October 25, 2013
Last Update Posted : October 25, 2013
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato

Brief Summary:
To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: PEB Device: PES Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2013
Estimated Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Active Comparator: PEB
PEB angioplasty plus provisional nitinol stent implantation
Device: PEB
Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation

Experimental: PES
Systematic PES angioplasty
Device: PES
Systematic Paclitaxel eluting stent angioplasty

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

Secondary Outcome Measures :
  1. Composite of all cause mortality, major amputation and target lesion revascularization. [ Time Frame: 12 months ]
    incidence of composite endpoint of all cause mortality, major amputation and target lesion revascularization.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • intermittent claudication or critical limb ischemia
  • de novo stenosis ≥ 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries
  • presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk
  • presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis >70%)

Exclusion Criteria:

  • life expectancy <1 year
  • contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel
  • need for major amputation (MA) at the time of enrolment
  • Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major amputation

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 identifier (NCT number): NCT01969630

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Cardiovascular Department, Ospedale S.Donato Recruiting
Arezzo, AR, Italy, 52100
Contact: Francesco Liistro, MD   
Principal Investigator: Leonardo Bolognese, MD, FESC         
Sub-Investigator: Giovanni Falsini, MD         
Sub-Investigator: Paolo Angioli, MD         
Sub-Investigator: Kenneth Ducci, MD         
Principal Investigator: Francesco Liistro, MD         
Sub-Investigator: Simone Grotti, MD         
Sub-Investigator: Italo Porto, MD         
Sponsors and Collaborators
Ospedale San Donato
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato Identifier: NCT01969630    
Other Study ID Numbers: Arezzo011
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013
Keywords provided by Leonardo Bolognese, MD, Ospedale San Donato:
femoropopliteal lesions
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases