Does Local Paclitaxel Improve the Efficacy of Balloon Angioplasty Without Stent Implantation for Treatment of Below the Knee Artery Lesions?
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 7
- Primary Endpoint
- Occlusion rate of the target lesion at 6 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
drug coated balloon versus uncoated balloon
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Drug coated balloon
SeQuentPlease OTW paclitaxel coated balloon catheter
Intervention: SequentPlease OTW paclitaxel coated balloon catheter (Device)
uncoated PTA balloon catheter
Standard of care uncoated BTK balloon catheter
Intervention: conventional uncoated balloon for BTK endovascular therapy (Device)
Outcomes
Primary Outcomes
Occlusion rate of the target lesion at 6 months
Time Frame: 6 +/- 1 months
by digital substraction angiogram or MRI
Secondary Outcomes
- target lesion revascularization(3, 6, 12 and 24 months)
Investigators
Prof. Dr. med. Gunnar Tepe
Director of the Deparment of Radiology, Clinical Professor
Klinikum Rosenheim