Outcomes of Straight-line Flow Versus Angiosome-targeted Angioplasty in Treatment of Critical Lower Limb Ischemia

NCT06127134 | Unknown DMC

• 1 other identifier: MSKU 50-2-28
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral arterial disease (PAD) affects more than 200 million people worldwide. Although over 50% are asymptomatic, it accounts for 4% of all amputations. The ischemic limb must be revascularized to help wound healing, reduce the pain of ischemia and preserve the limb's function. So, surgical and percutaneous revascularization choices must be considered in CLI. Classically, CLI revascularization aims to provide at least one patent vessel that delivers in-line flow to the foot. Today, the investigators live in a new era of angioplasty evolving and substituting open vascular surgery, so expanding research on endovascular strategy has been noticed.This confirms the profound impact of angioplasty in vascular surgery as one of the fastest-growing branches of medicine Infrapopliteal artery occlusive disease (IPOD) is a significant cause of critical limb-threatening ischemia (CLTI). The worldwide prevalence of IPOD is between 4.5% and 29%, and most patients live in low-income countries. The angiosomal concept was derived from plastic surgery for the skin flap. This concept delineates the human body into three-dimensional blocks of tissue from the skin to bone and also provides practical application of vascular anatomy for reconstructive surgery. An angiosome is an anatomic unit of tissue consisting of skin, subcutaneous, muscle, and bone fed by a source artery and drained by a specific vein. According to the angiosomal concept, the foot is divided into six distinct angiosomes fed by source arteries, three from the posterior tibial, two from the peroneal, and one from the anterior tibial artery, with functional artery-to-artery connections among muscle, fascia, and skin. Numerous direct inter-arterial connections occur between the foot's main arteries, which provide alternative pathways of blood flow when disruption or compromise affects the arteries that directly feed the angiosome. On the other hand, in patients with CLI, where only one vessel runoff can be established to the foot, direct flow into a patent pedal arch is essential to improve their clinical outcomes. Conventional Endovascular therapy aims to the re-establishment of pulsatile straight-line flow to the lower limb. This results in relieving ischemic pain, healing ulcers, achieving limb salvage, improving quality of life, and potentially prolonging survival. So it became essential to know the differential impact of both concepts on CLI revascularization.

Conditions

Angioplasty; Critical Lower Limb Ischemia

Keywords

angioplasty; critical lower limb ischemia; chronic lower limb threatening ischemia; straight line; angiosome

Outcome Measures

Primary Outcomes (2)

• Technical success

  good distal flow and arterial pulsation which are documented by angiography pre \& post procedure with residual stenosis \<30%

  first 24 hours

• Clinical success

  limb salvage and wound status improves at least one class in Rutherford classification in patients with critical limb ischemia.

  first 6 month

Study Arms (2)

Straight-line flow (Group A)

ACTIVE COMPARATOR

treating less diseased arteries which is in line with distal run off the foot

Procedure: peripheral angioplasty for tibial vessels

Angiosome-targeted (Group B)

SHAM COMPARATOR

treating specific angiosome through a targeted vessel which mainly supplies this angiosome

Procedure: peripheral angioplasty for tibial vessels

Interventions

peripheral angioplasty for tibial vessels PROCEDURE

repair tibials blood vessels throughout two concepts using angioplasty ballooning

Also known as: endovascular arterial repair for critical lower limb ischemia

Angiosome-targeted (Group B); Straight-line flow (Group A)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with documented symptomatic infragenicular chronic arterial disease with or without supra-genicular lesion
• Diabetic or not
• Rutherford grades 4, 5 and 6
• The patient is able and willing to comply with study follow-up requirements.

You may not qualify if:

• Contraindication for angioplasty
• unsuitable for angioplasty revascularization strategy
• claudication case
• tissue loss is considered to be primarily of venous etiology.
• Patient with full-thickness gangrene of the foot.
• Widespread infection of the lower limb needing amputation

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Egypt

Location

Study Officials

• Ahmed M Bedeer, MD

  KFS university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: January 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: January 1, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

EG (1)