Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment

Last updated: March 9, 2020
Sponsor: Jena University Hospital
Overall Status: Completed

Phase

N/A

Condition

Peripheral Arterial Disease (Pad)

Thrombosis

Peripheral Arterial Occlusive Disease

Treatment

N/A

Clinical Study ID

NCT02539940
4448-06/15
  • Ages > 18
  • All Genders

Study Summary

The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Paclitaxel-eluting balloon angioplasty in below-the-knee lesions with ELUTAX SV-DEB

  • Age ≥ 18 years

  • Signed informed consent

  • documented Critical Limb Ischemia (CLI) in the target limb prior to the study

  • Rutherford Category 4, 5 or 6

  • ≥70% diameter stenosis or occlusion in the target lesion, including de-novo / in-stentrestenosis/occlusion of target lesion

  • Patent inflow artery

  • Target vessel(s) diameter between 2 and 4 mm

  • Target vessel(s) reconstitute(s) at or above the ankle

Exclusion

Exclusion Criteria:

  • Life expectancy below 50% within the next 12 months (as judged by the investigator)

  • Planned major index limb amputation

  • Acute limb ischemia (within last 14 days thrombectomy, atherectomy, or lysis)

  • Application of DEB-eluting balloons except from ELUTAX SV in the same target limb (POBA is allowed)

  • Patient unwilling or unlikely to comply with follow-up schedule

Study Design

Total Participants: 166
Study Start date:
September 01, 2015
Estimated Completion Date:
October 31, 2018

Study Description

The management of critical limb ischemia due to below-the-knee disease remains challenging due to the frequent patient comorbidities, diffuse vascular involvement, limb preservation, and high rates of restenosis and disease progression. This study will record the use of ELUTAX SV-DEB under real life conditions in a representative sample.The investigators will generate new data in observing the outcome and the safety of the Elutax SV drug-eluting balloons for change in Rutherford clinical category from baseline to 6 and 12 month follow-up visits.

Connect with a study center

  • DRK Kliniken Berlin Köpenick

    Berlin, Brandenburg
    Germany

    Site Not Available

  • Oberlausitz-Kliniken Bautzen

    Bautzen, Saxony 02625
    Germany

    Site Not Available

  • Städtisches Krankenhaus Dresden-Friedrichstadt

    Dresden, Saxony 01067
    Germany

    Site Not Available

  • Heinrich-Braun-Krankenhaus

    Zwickau, Saxony 08060
    Germany

    Site Not Available

  • Klinikum Altenburger Land GmbH

    Altenburg, Thuringia 046600
    Germany

    Site Not Available

  • SRH-Waldklinikum

    Gera, Thuringia 07548
    Germany

    Site Not Available

  • University Hospital Jena, Radiology

    Jena, Thuringia 07747
    Germany

    Site Not Available

  • MEDINOS Kliniken Sonneberg

    Sonneberg, Thuringia 96515
    Germany

    Site Not Available

  • Saale-Unstrut Klinikum Naumburg

    Naumburg, Thüringen 06618
    Germany

    Site Not Available

  • Kreiskrankenhaus Torgau "J. Kentmann" gGmbH

    Torgau, 04860
    Germany

    Site Not Available

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