Local Paclitaxel or Balloon Angioplasty Below the Knee

Prof. Dr. med. Gunnar Tepe120 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Stenosis Occlusion Restenosis

Interventions

SequentPlease OTW paclitaxel coated balloon catheterDEVICE

PTA with SequentPlease OTW paclitaxel coated balloon catheter

conventional uncoated balloon for BTK endovascular therapyDEVICE

PTA with uncoated balloon for BTK endovascular therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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 radiation therapy

Locations (7)

LKH-Univ. Klinikum Graz

Graz, Austria

NOT_YET_RECRUITING

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, Germany

NOT_YET_RECRUITING

Tepe

Rosenheim, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

Occlusion rate of the target lesion at 6 months

by digital substraction angiogram or MRI

Time frame: 6 +/- 1 months

Secondary Outcomes

target lesion revascularization

repeat intervention

Time frame: 3, 6, 12 and 24 months

Central Contacts

Gunnar Tepe, MD

CONTACT

+498031365 gunnar.tepe@ro-med.de

Data from ClinicalTrials.gov

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