Drug Coated Balloon
Conditions
Brief summary
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
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)
Interventions
DEVICEdrug coated balloon
use of drug coated balloon in treatment of critical limb ischemia
Sponsors
Assiut University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from device- and procedure-related mortality | 30 days | mortality related to procedure |
| 30 days clinically driven target vessel revascularization | 30 days | patency rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse events | 12 months | major adverse events as amputation |
| 1 year clinically driven target vessel revascularization | 12 months | patency rate |
Contacts
Primary Contactahmed nageeb, master
Outcome results
None listed