Role and Outcome of Endovascular Revascularization of Chronic Limb Ischaemia

Role and Outcome of Endovascular Revacularization of Chronic Limb Threatening Ischaemia in Patients With Chronic Kidney Diseases

identify the safety and efficacy of percutaneous transluminal angioplasty in critical limb ischaemia patients with chronic kidney dieases

Study Overview

• Status: Not yet recruiting
• Conditions: Limb Ischemia, Critical

Detailed Description

patients with chronic kidney diseases are at higher risk of developing peripheral artery diseases needing revascularization of diseased arteries via endovascular transluminal angioplasty

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients fulfilled these criteria will be included in this study as an availability sample for year duration sample size : 100 patients

Description

Inclusion Criteria:

• all patients with chronic kidney diseases on medical treatment or on dialysis and have critical limb ischaemia

Exclusion Criteria:

• patients with acute renal failure and lower limb ischaemia.
• chronic kidney diseased patients underwent previous intervention or surgery for lower limb ischaemia.
• patients presented with acute limb ischaemia

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
one year evaluation for maintaining vessel patency without restenosis or need for re intervention in 100 participants	all patients will be scheduled for follow up visits every 3 months for 1 year assessing primary patency and major adverse limb events. duplex scanning will be performed for all patients	baseline

Collaborators and Investigators

• Sponsor: Mahmoud Abdelmohsen Mostafa Osman

Publications and helpful links

General Publications

• Dayama A, Tsilimparis N, Kolakowski S, Matolo NM, Humphries MD. Clinical outcomes of bypass-first versus endovascular-first strategy in patients with chronic limb-threatening ischemia due to infrageniculate arterial disease. J Vasc Surg. 2019 Jan;69(1):156-163.e1. doi: 10.1016/j.jvs.2018.05.244.
• Imamura T. Optimal therapeutic strategy for those with chronic kidney disease and peripheral artery disease receiving peripheral vascular intervention. Clin Cardiol. 2020 Dec;43(12):1348. doi: 10.1002/clc.23483. Epub 2020 Oct 19. No abstract available.
• Moussa Pacha H, Al-Khadra Y, Darmoch F, Soud M, Mamas MA, Moussa Pacha A, Zaitoun A, Kaki A, AlJaroudi WA, Alraies MC. In-hospital outcome of peripheral vascular intervention in dialysis-dependent end-stage renal disease patients. Catheter Cardiovasc Interv. 2020 Feb 15;95(3):E84-E95. doi: 10.1002/ccd.28522. Epub 2019 Oct 21.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: November 26, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Estimate): December 8, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: endovascular treatment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No