Drug Eluting Balloon (DEB) and Long Lesions of Superficial Femoral Artery (SFA) Ischemic Vascular Disease (DEB-SFA-LONG)

September 30, 2016 updated by: Ettore Sansavini Health Science Foundation

Safety and Efficacy of the Drug Eluting Balloon (DEB) for the Treatment of the Superficial Femoral Artery (SFA) Ischemic Vascular Disease in Symptomatic Patients Presenting With Long Lesions: a Pilot Study

The primary purpose of this study is to assess safety and efficacy of the Drug Eluting Balloon (DEB) technology for the treatment of the Superficial Femoral Artery (SFA) ischemic obstructive vascular disease in patients presenting with long lesions. As secondary aim this study is going to explore treatment effect on a number of procedural and clinical endpoints in order to collect information to design a future comparative effectiveness study.

Study Overview

Status

Completed

Detailed Description

The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Eluting Balloon (DEB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions.

The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DEB currently available on the market.

Study Type

Observational

Enrollment (Actual)

105

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

      • Bari, Italy, 70124
        • Anthea Hospital
      • Lecce, Italy, 73100
        • Città di Lecce Hospital
      • Palermo, Italy, 90141
        • Maria Eleonora Hospital, GVM Care & Research
      • Rapallo, Italy
        • ICLAS Rapallo
      • Torino, Italy
        • Maria Pia Hospital
    • Ravenna
      • Cotignola, Ravenna, Italy, 48010
        • Maria Cecilia Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients affected by lower extremities artery disease (LEAD) and referred to the participating centres for the endovascular treatment of de novo or restenotic lesions (no in stent restenosis) in the superficial femoral and proximal popliteal arteries will be considered for the study

Description

Inclusion Criteria:

  • Documented ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4;
  • Target lesion consists of a single solitary or multiple adjacent de novo or restenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm;
  • Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee);
  • Life expectancy >1 year in the Investigator's opinion;
  • Written informed consent.

Exclusion criteria:

Given the observational nature of the study, no study-specific but only clinical exclusion criteria will apply:

  • Patient unwilling or unlikely to comply with FU schedule;
  • Administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure;
  • Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel;
  • Additional planned cardiac or peripheral percutaneous or surgical intervention including CABG within 30 days following the study procedure;

    • 15 cm long inflow lesion (≥50% DS) or occlusion (any length) in the ipsilateral Iliac artery;
  • Failure to successfully treat < 15 cm long inflow lesion in the ipsilateral Iliac artery

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of primary patency
Time Frame: within the first 12 months after percutaneous treatment
Primary patency is defined as freedom from the combined endpoints of clinically-driven target lesion revascularization (TLR) and >50% restenosis in the treated lesion. Clinically driven TLR is defined as any re-intervention within the target lesion due to symptoms or drop of ABI of ≥20% or >0.15 when compared to post-procedure. Restenosis > 50% is defined by a peak systolic velocity ratio (PSVR) > 2.4.
within the first 12 months after percutaneous treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite of all Major Adverse Events (MAE)
Time Frame: within the first 24 months after percutaneous treatment
evaluate the incidence of the composite of all Major Adverse Events (MAE) through 24 months i.e. the first occurrence of any of the following: death from any cause, major target limb amputation, thrombosis at the target lesion site
within the first 24 months after percutaneous treatment
incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE)
Time Frame: within the first 24 months after percutaneous treatment
to assess the incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE) individual components through 24 months
within the first 24 months after percutaneous treatment
clinical improvement as assessed by Rutherford Class changes
Time Frame: within 6, 12 and 24 months vs baseline
compare clinical improvement as assessed by Rutherford Class changes at 6, 12 and 24 months with respect to baseline
within 6, 12 and 24 months vs baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of instrumental restenosis
Time Frame: within the first 24 months after percutaneous treatment
the rate of instrumental restenosis as determined by duplex ultrasound Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 post-index procedure and the rate of instrumental restenosis as determined by duplex ultrasound Peak Systolic Velocity Ratio (PSVR) ≤2 and ≤3.5 at 12 months (6, and 24 if available) or at unscheduled visit, as evaluated by an independent core lab
within the first 24 months after percutaneous treatment
procedural success rate
Time Frame: at the end of percutaneous treatment
rate of procedural success i.e. complete revascularization in the absence of peri-procedural complications
at the end of percutaneous treatment
walking capacity and quality of life
Time Frame: whithin 6, 12 and 24 months post-procedure vs. baseline
walking capacity as assessed by walking impairment questionnaire (WIQ) and quality of life (EQ5D questionnaire) at 6, 12 and 24 months post-procedure vs. baseline
whithin 6, 12 and 24 months post-procedure vs. baseline

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Antonio Micari, MD, Maria Eleonora Hospital, GVM Care & Research

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.

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, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

August 2, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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