Drug Coated Ballon in Critical Limb Ischemia (DCB)

Assiut University

Status

Unknown

Conditions

Drug Coated Balloon

Treatments

Device: drug coated balloon

Study type

Interventional

Funder types

Other

Identifiers

NCT04737291

drug coated balloon

Details and patient eligibility

About

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

Full 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)

Enrollment

36 estimated patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

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