NCT05209672

Brief Summary

Critical limb threatening ischemia "CLTI 'is not a separate local disease but also it is a part of generalized vascular disorder. A clinical syndrome that can be presented by many symptoms and signs as rest pain, gangrene and chronic ulceration more than 2 weeks (1).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

December 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

December 13, 2021

Last Update Submit

January 24, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Imitate technical failure

    Failure of passage of wire or Recoil of vessels during angioplasty

    1 year

  • Limb based patency at 1 year

    Patent vessels after endovascular management

    1 year

Secondary Outcomes (3)

  • Amputation free survival at 1 year

    1 year

  • Mortality Rate at 1 year

    1 year

  • Amputation rate at 1 year

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients attending the Vascular Surgery Clinics in Assiut University Hospitals with infra inguinal CLTI will be recruited to participate in the study. Based on high quality angiography, patients presented with CLTI will be assigned into 3 stages according to GLASS

You may qualify if:

  • Patients with infrainguinal CLTI

You may not qualify if:

  • Patients with concomitant Aorto-iliac lesions
  • Acute ischemia patients
  • Post Traumatic ischemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Assiut University

Asyut, Egypt

Location

Related Publications (1)

  • Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8.

    PMID: 31182334BACKGROUND

Central Study Contacts

Haitham Ali Hassan, MD

CONTACT

Ayman Elsayed Hassaballah, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 13, 2021

First Posted

January 26, 2022

Study Start

March 1, 2022

Primary Completion

February 1, 2023

Study Completion

March 1, 2023

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations