Limb Ischemia, CriticalNCT05643378
Role and Outcome of Endovascular Revascularization of Chronic Limb Ischaemia
An observational study of Limb Ischemia, Critical, run by Mahmoud Abdelmohsen Mostafa Osman.
Trial summary
identify the safety and efficacy of percutaneous transluminal angioplasty in critical limb ischaemia patients with chronic kidney dieases Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Limb Ischemia, Critical
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: all patients fulfilled these criteria will be included in this study as an availability sample for year duration sample size : 100 patients
Who may be able to join
- all patients with chronic kidney diseases on medical treatment or on dialysis and have critical limb ischaemia
Who cannot join
- 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
About this study
Official title: 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
Read the 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
- Conditions
- Limb Ischemia, Critical
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Limb Ischemia, CriticalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Abdelmohsen Mostafa Osman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Abdelmohsen Mostafa Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643378
- Sponsor's protocol ID
- endovascular treatment
- Status last verified
- Dec 2022
- First submitted
- 26 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30579443Imamura 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.
PubMed 33073876Moussa 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.
PubMed 31631511
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role and Outcome of Endovascular Revacularization of Chronic Limb Threatening Ischaemia in Patients With Chronic Kidney Diseases
- ClinicalTrials.gov ID
- NCT05643378
- Acronym / sponsor ID
- endovascular treatment
- Conditions
- Limb Ischemia, Critical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahmoud Abdelmohsen Mostafa OsmanUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
identify the safety and efficacy of percutaneous transluminal angioplasty in critical limb ischaemia patients with chronic kidney dieases
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients fulfilled these criteria will be included in this study as an availability sample for year duration sample size : 100 patients
Key inclusion criteria (1 listed)
- all patients with chronic kidney diseases on medical treatment or on dialysis and have critical limb ischaemia
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
one year evaluation for maintaining vessel patency without restenosis or need for re intervention in 100 participants
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Background: PubMed 30579443Dayama 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.
- Background: PubMed 33073876Imamura 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.
- Background: PubMed 31631511Moussa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Ischemia, Critical, run by Mahmoud Abdelmohsen Mostafa Osman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one year evaluation for maintaining vessel patency without restenosis or need for re intervention in 100 participants (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05643378, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.