Role and Outcome of Endovascular Revascularization of Chronic Limb Ischaemia
Sponsor
Mahmoud Abdelmohsen Mostafa Osman (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05643378
Collaborator
(none)
100
10
Study Details
Study Description
Brief Summary
identify the safety and efficacy of percutaneous transluminal angioplasty in critical limb ischaemia patients with chronic kidney dieases
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Role and Outcome of Endovascular Revacularization of Chronic Limb Threatening Ischaemia in Patients With Chronic Kidney Diseases
Anticipated Study Start Date
:
Dec 1, 2022
Anticipated Primary Completion Date
:
Sep 1, 2023
Anticipated Study Completion Date
:
Oct 1, 2023
Outcome Measures
Primary Outcome Measures
- one year evaluation for maintaining vessel patency without restenosis or need for re intervention in 100 participants [baseline]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mahmoud Abdelmohsen Mostafa Osman
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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.
Responsible Party:
Mahmoud Abdelmohsen Mostafa Osman,
principle investigator,
Assiut University
ClinicalTrials.gov Identifier:
NCT05643378
Other Study ID Numbers:
- endovascular treatment
First Posted:
Dec 8, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: