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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No