Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty

Study Overview
=================
Brief Summary
-----------------
The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries was terminated. The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss. The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss.

Detailed Description
-----------------
Although the association between the drug coated balloon (DCB) therapy and limb outcomes could not be clearly linked to the use of antiproliferative agents, the findings of paclitaxel crystals downstream of the treated lesions, although in small amounts, has raised concerns about the safety of such therapy in patients with critical limb ischemia (CLI) and tissue loss. These concerns, however, may not translate to patients with femoropopliteal occlusive disease as the amount of paclitaxel reaching the foot may be even smaller after being filtered by the calf musculature. Since the use of DCB angioplasty in the Superficial Femoral Artery (SFA) and popliteal has been shown to deliver significantly more durable outcomes compared to standard angioplasty alone, with reported primary patency rates of almost 90% at one year, this therapy may even be more needed in patients with tissue loss where prolonged patency is essential for wound healing.

Official Title
-----------------
Evaluation of Paclitaxel in Patients With CLI (Critical Limb Ischemia) and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty

Conditions
-----------------
Ischemia

Intervention / Treatment
-----------------
* Device: Angiogram, Medtronic DCB (paclitaxel)/stent
* Device: Angiogram, Bard DCB (paclitaxel)/stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient population: all patients with CLI (critical limb ischemia) and tissue loss scheduled for endovascular intervention for femoral popliteal occlusive or multilevel disease. Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 5 or 6 General Angiographic Inclusion Criteria Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in the SFA and/or popliteal arteries. Iliac inflow or Tibial outflow interventions can be done at the discretion of the investigator with standard balloon Percutaneous Transluminal Angioplasty (PTA) Exclusion Criteria: Patient unwilling or unlikely to comply with Follow-Up schedule Aneurysm in the target vessel Acute thrombus in the target limb Sensitivity to Paclitaxel Immunosuppressed patients (transplant, chemotherapy, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 95 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Critical Limb Ischemia (CLI) and Tissue Loss<br>Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Patients with CLI will receive either Angiogram, Medtronic DCB (paclitaxel)/stent or Angiogram, Bard DCB (paclitaxel)/stent | Device: Angiogram, Medtronic DCB (paclitaxel)/stent<br>* Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Each participant will receive angiogram with DCB (drug coated balloon)/stenting with wound debridement. 50% of subjects will receive an Angiogram, Medtronic DCB (paclitaxel)/stent. Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.<br>Device: Angiogram, Bard DCB (paclitaxel)/stent<br>* Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. 50% of subjects will receive 'Angiogram, Bard DCB (paclitaxel)/stent' . Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing | Percentage of participants with wound healing defined as > 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year. | 12 months | 
| Amputation Free Survival | Percentage of participants with a 1 year amputation free survival. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency ( determine if vessel remains open) | Prospective duplex ultrasound will be performed at the intervals listed to verify (primary and secondary) patency of targeted vessels. Assessment of severe restenosis and reinterventions will be determined | 3, 6, 12 months | 
| Rate of severe stenosis (narrowing) and reinterventions | Severe stenosis (>50%) evaluated by Duplex ultrasound at 1,3,6 and 12 month intervals | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critical lower limb ischemia with tissue loss