Drug Coated Ballon in Critical Limb Ischemia

Study Overview
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Brief Summary
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Evaluate the safety and efficacy of drug coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with critical limb ischemia (CLI)

Detailed Description
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Critical limb ischemia (CLI) is the most advanced stage of peripheral artery disease (PAD); which is estimated to affect more than 200 million people worldwide.(1) CLI classified as Rutherford category (RC) 4-6, includes ischemic rest pain and tissue loss.(2) The first line revascularization strategy for patients with CLI is endovascular percutaneous transluminal angioplasty (PTA).(3) The treatment of femoropopliteal lesions displays a huge anatomic challenge as this segment serves various biomechanical functions, Which makes endovascular treatment is challenging.(4) Plain balloon (PB) angioplasty for femoropopliteal artery disease has a high rate of procedural success and an acceptable safety profile, in spite of initially encouraging technical success after femoropopliteal (PTA), postprocedural restenosis remains the major challenge(5) Excessive extracellular matrix material synthesized by activated smooth muscle cells (SMC) in the media of the arteries leads to Neointimal hyperplasia and restenosis.(6) Restenosis resulting in loss of primary patency, late lumen loss (LLL), occlusion and/or the need for target lesion revascularization (TLR).(7) Drug-coated balloons (DCBs) inhibit the neointimal hyperplasia, the biological mechanism of restenosis formation, by application of cytostatic agents in a local therapeutic concentration.(8) The antiproliferative paclitaxel (PTX) seems to be the most effective therapeutic agent for DCBs due to local retention in the arterial wall.(9)

Official Title
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Outcomes of Drug Coated Balloon Angioplasty for Femoropopliteal Lesions in Patients With Critical Limb Ischemia

Conditions
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Drug Coated Balloon

Intervention / Treatment
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* Device: drug coated balloon


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adults at least 18 years of age with critical lower limb ischemia (Rutherford category 4, 5), stenotic (≥70% by visual angiographic assessment) or occlusive lesions in the native SFA or PPA, and vessel diameter ≥4 and ≤6 mm were eligible. Total lesion length ≤190 mm (visual angiographic assessment). DE novo angioplasty Recurrent or recoil lesion Exclusion criteria: pregnancy breast feeding iliac lesions Malignancy Patients with raised renal chemistry. Patients with contraindication to antiplatelet therapy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angioplasty by DCB<br>angioplasty of stenotic , ocluded or recoil segment using drug coated ballon | Device: drug coated balloon<br>* use of drug coated balloon in treatment of critical limb ischemia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device- and procedure-related mortality | mortality related to procedure | 30 days | 
| 30 days clinically driven target vessel revascularization | patency rate | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse events | major adverse events as amputation | 12 months | 
| 1 year clinically driven target vessel revascularization | patency rate | 12 months |