Drug Coated Ballon in Critical Limb Ischemia

Not Applicable

• Conditions: Drug Coated Balloon
• Interventions: Device: drug coated balloon

• Registration Number: NCT04737291
• Lead Sponsor: Assiut University

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)

Study Timeline

• Study First Submitted: 2021-01-13
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-02
• Last Update Submitted: 2021-02-02
• Study First Posted: 2021-02-03
• Last Update Posted: 2021-02-03
• Study Start: 2021-03-15
• Primary Completion: 2022-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Angioplasty by DCB	drug coated balloon	angioplasty of stenotic , ocluded or recoil segment using drug coated ballon

Primary Outcome Measures

Name	Time	Method
30 days clinically driven target vessel revascularization	30 days	patency rate
Freedom from device- and procedure-related mortality	30 days	mortality related to procedure

Secondary Outcome Measures

Name	Time	Method
1 year clinically driven target vessel revascularization	12 months	patency rate
Major adverse events	12 months	major adverse events as amputation