NCT05643378

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

November 26, 2022

Last Update Submit

December 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 30579443BACKGROUND
  • 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.

    PMID: 33073876BACKGROUND
  • 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.

    PMID: 31631511BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

November 26, 2022

First Posted

December 8, 2022

Study Start

December 1, 2022

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

December 8, 2022

Record last verified: 2022-12