Pedal Arch Revascularization in Patients With Chronic Limb Threatening Ischemia

• Conditions: Critical Ischemia of Foot
• Interventions: Procedure: angioplasty

• Registration Number: NCT05098548
• Lead Sponsor: Assiut University

Brief Summary

Chronic limb threatening ischemia (CLTI) is a major cause of morbidity and mortality worldwide and is characterized by multilevel disease, often involving the tibiopedal vessels . CLTI is an undesirable clinical consequence of peripheral arterial disease (PAD) . It affected ∼8 million people in the USA and affects 12-20% of American people aged more than 65 years. Within 1 year of diagnosis, 25% of those patients progress to a major amputation and the other 25% die due to co-morbid conditions

Detailed Description

Revascularization is the cornerstone of Chronic limb threatening ischemia (CLTI) treatment for lower limb preservation . Endovascular revascularization is the favored approach in many centers because of its lower morbidity and mortality than open surgery . In a subset of patients with Chronic limb threatening ischemia, particularly in longstanding type 1 diabetic patients, a predominance of disease involving the pedal vessels can exist with relative sparing of the tibial vessels .The pedal arch describes the connection between the anterior and posterior circulation in the foot, this typically runs from the lateral plantar artery into the dorsalis pedis and represents the final arcade of outflow for the lower extremity vasculature . Secondary or "deep" pedal plantar loops connecting the medial and lateral tarsal arteries to the medial and lateral plantar arteries can also exist . A strong understanding of the pedal arch anatomy and its multiple connections is important for the physician performing not only pedal arch interventions, but tibial interventions as well . Familiarity with the arch anatomy increases procedural success rates in tibial intervention, as it gives the operator another collateral pathway to approach the target occlusion in a retrograde fashion . An intact pedal arch has been associated with improved wound healing, as well as a higher patency rate for bypass grafting and percutaneous interventions for inflow disease . An Angio some-directed revascularization strategy, however, has clearly been shown to improve wound healing and limb salvage rates in both surgical and endovascular series . Pedal arch intervention should therefore be considered in patients with advanced tissue loss, with a goal of restoring inline flow to the corresponding angiosomes, this could mean the difference between a major and minor amputation, as the options for these patients are limited and major amputation rates are high .

Study Timeline

• Study First Submitted: 2021-10-16
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-10-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-28
• Study Start: 2022-12-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

All patients with Chronic limb threatening ischemia present with one or more of the following:

• Rest pain (Rutherford category 4)
• Minor tissue loss (Rutherford category 5) admitted to the department of Vascular surgery for Endovascular Intervention with provided written informed consent.

Exclusion Criteria

• Patients presented with proved vasculitis.
• Patients with Chronic liver disease if there is prolonged PT.
• Patients with Heart failure if the patient is orthopneic and cannot lay on table for long time).
• Patients with impaired renal function.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with Chronic limb threatening ischemia	angioplasty	All patients with Chronic limb threatening ischemia present with one or more of the following: 1. Rest pain (Rutherford category 4) 2. Minor tissue loss (Rutherford category 5) admitted to the department of Vascular surgery for Endovascular Intervention with provided written informed consent.

Primary Outcome Measures

Name	Time	Method
Patency of the vessel	From December 2021 to April 2022	Primary patency Which means maintaining vessel patency without restenosis or need for re-intervention .