Local Paclitaxel or Balloon Angioplasty Below the Knee

Last updated: May 10, 2017
Sponsor: Prof. Dr. med. Gunnar Tepe
Overall Status: Active - Recruiting

Phase

N/A

Condition

Occlusions

Treatment

N/A

Clinical Study ID

NCT03149913
BTK 1
  • Ages > 18
  • All Genders

Study Summary

Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • >18 years of age

  • Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries

  • Rutherford 2-5 patients

  • Patients with ≤ 2 BTK lesions (≥ 70% diameter stenosis)

  • Lesion length limited to 5-25 cm

Exclusion

Exclusion Criteria:

  • Planned or foreseeable amputation

  • Previous amputation at the index limb

  • Index vessel with no run-off to the foot distal to the index lesion

  • Prior treatment of the index lesion with a drug coated balloon

  • In-stent restenosis

  • Life expectancy <1 year

  • Known creatinine >1.4 mg% if patient is not on dialysis

  • Acute thrombus in the index limb

  • Aneurysm in the index leg

  • Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel,abciximab, paclitaxel

  • Patients with concomitant medical illnesses that require cytostatic or radiationtherapy

Study Design

Total Participants: 120
Study Start date:
December 15, 2016
Estimated Completion Date:
July 31, 2020

Study Description

After successful guide wire passage of the below the knee index lesions the patients will either receive a treatment with a conventional uncoated balloon or a balloon coated with paclitaxel. Only patients who require follow-up angiography after 6 months will be included in this study. The primary endpoint (index vessel occluded or still open) is at 6 months - the patients will be also followed for 24 months for clinical endpoints. In addition an MRI is planned at 12 months.

Connect with a study center

  • LKH-Univ. Klinikum Graz

    Graz,
    Austria

    Site Not Available

  • Herzzentrum Bad Krozingen

    Bad Krozingen, BW 73000
    Germany

    Site Not Available

  • Tepe

    Rosenheim, BW 83022
    Germany

    Active - Recruiting

  • Klinikum Arnsberg

    Arnsberg,
    Germany

    Site Not Available

  • Ev.-Luth. Diakonissenanstalt zu Flensburg

    Flensburg,
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Mülheim a. d. Ruhr

    Mülheim, 45468
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg,
    Germany

    Site Not Available

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