Clinical trial NCT04737291: Drug Coated Ballon in Critical Limb Ischemia
Official title: Outcomes of Drug Coated Balloon Angioplasty for Femoropopliteal Lesions in Patients With Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug Coated Balloon
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Freedom from device- and procedure-related mortality
timeFrame: 30 days
measure: 30 days clinically driven target vessel revascularization
timeFrame: 30 days
Secondary outcomes:
measure: Major adverse events
timeFrame: 12 months
measure: 1 year clinically driven target vessel revascularization
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: hassan bakr, professor
role: STUDY_CHAIR
affiliation: Assiut University
name: mahmoud ismael, ass profesor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: osman mahmoud, lecturer
role: PRINCIPAL_INVESTIGATOR
References: