Clinical trial NCT03149913: Local Paclitaxel or Balloon Angioplasty Below the Knee
Official title: Does Local Paclitaxel Improve the Efficacy of Balloon Angioplasty Without Stent Implantation for Treatment of Below the Knee Artery Lesions?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stenosis
Occlusion
Restenosis
Keywords: below the knee artery
endovascular
drug coated balloon
critical limb ischemia
Lead sponsor: Klinikum Rosenheim
Sponsor class: OTHER
Collaborators: name: InnoRa GmbH
First posted: 2017-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The vessel patency (measured by angiography at 6 months) will be compared after patients have been treated either with paclitaxel coated or uncoated balloons (control) in BTK arteries
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occlusion rate of the target lesion at 6 months
timeFrame: 6 +/- 1 months
Secondary outcomes:
measure: target lesion revascularization
timeFrame: 3, 6, 12 and 24 months
Other outcomes:
measure: Walking distance
timeFrame: 3, 6, 12 and 24 months
measure: Wound status
timeFrame: 3, 6, 12 and 24 months
Locations:
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
state: BW
city: Rosenheim
country: Germany
facility: Tepe
state: BW
city: Arnsberg
country: Germany
facility: Klinikum Arnsberg
city: Flensburg
country: Germany
facility: Ev.-Luth. Diakonissenanstalt zu Flensburg
city: Mülheim
country: Germany
facility: Evangelisches Krankenhaus Mülheim a. d. Ruhr
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
Study officials:
affiliation: RoMed Klinikum Rosenheim
name: Gunnar Tepe, MD
role: PRINCIPAL_INVESTIGATOR
References: