Drug Coated Ballon in Critical Limb Ischemia

Drug Coated Balloon Clinical Trial

— DCB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04737291
• Other study ID #: drug coated balloon
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: March 2023

Study information

• Verified date: February 2021
• Source: Assiut University
• Contact: ahmed nageeb, master
• Phone: 01096192891
• Email: a7mednageeb[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: March 2023
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Coated Balloon
• Ischemia

Intervention

Device:
• drug coated balloon
use of drug coated balloon in treatment of critical limb ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device- and procedure-related mortality	mortality related to procedure	30 days
Primary	30 days clinically driven target vessel revascularization	patency rate	30 days
Secondary	Major adverse events	major adverse events as amputation	12 months
Secondary	1 year clinically driven target vessel revascularization	patency rate	12 months