Local Paclitaxel or Balloon Angioplasty Below the Knee

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.

Official Title
-----------------
Does Local Paclitaxel Improve the Efficacy of Balloon Angioplasty Without Stent Implantation for Treatment of Below the Knee Artery Lesions?

Conditions
-----------------
Stenosis, Occlusion, Restenosis

Intervention / Treatment
-----------------
* Device: SequentPlease OTW paclitaxel coated balloon catheter
* Device: conventional uncoated balloon for BTK endovascular therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug coated balloon<br>SeQuentPlease OTW paclitaxel coated balloon catheter | Device: SequentPlease OTW paclitaxel coated balloon catheter<br>* PTA with SequentPlease OTW paclitaxel coated balloon catheter<br>|
| Active Comparator: uncoated PTA balloon catheter<br>Standard of care uncoated BTK balloon catheter | Device: conventional uncoated balloon for BTK endovascular therapy<br>* PTA with uncoated balloon for BTK endovascular therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion rate of the target lesion at 6 months | by digital substraction angiogram or MRI | 6 +/- 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target lesion revascularization | repeat intervention | 3, 6, 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critical limb ischemia, below the knee artery, endovascular, drug coated balloon