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

October 21, 2013 updated by: Leonardo Bolognese, MD, Ospedale San Donato
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AR
      • Arezzo, AR, Italy, 52100
        • Recruiting
        • Cardiovascular Department, Ospedale S.Donato
        • Principal Investigator:
          • Leonardo Bolognese, MD, FESC
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
angiographic binary restenosis
Time Frame: 12 months
incidence of binary restenosis
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Donato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Estimate)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 21, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arezzo011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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