Drug Coated Ballon in Critical Limb Ischemia

NCT ID: NCT04737291

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2023-03-31

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)

Conditions

Drug Coated Balloon

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Angioplasty by DCB

angioplasty of stenotic , ocluded or recoil segment using drug coated ballon

Group Type: EXPERIMENTAL

drug coated balloon

Intervention Type: DEVICE

use of drug coated balloon in treatment of critical limb ischemia

Interventions

drug coated balloon

use of drug coated balloon in treatment of critical limb ischemia

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Nageeb

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hassan bakr, professor

Role: STUDY_CHAIR

Assiut University

mahmoud ismael, ass profesor

Role: STUDY_DIRECTOR

Assiut University

osman mahmoud, lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

ahmed nageeb, master

Role: CONTACT

a7mednageeb@aun.edu.eg

01096192891

Other Identifiers

drug coated balloon

Identifier Type: -

Identifier Source: org_study_id