NCT05547022

Brief Summary

The purpose of this study was to investigate limb salvage rates in patients with critical limb ischemia after endovascular revascularization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

September 15, 2022

Last Update Submit

August 23, 2023

Conditions

Limb Salvage Rates With Endovascular Therapy

Keywords

Critical limb-threatening ischemia (CLTI); Endovascular revascularization (EVR); Peripheral arterial disease (PAD); Peripheral vascular disease (PVD).

Outcome Measures

Primary Outcomes (1)

  • Primary outcome

    to determine the success rate of target lesion revascularization using endovascular limb salvage techniques

    2 to 3 years

Other Outcomes (2)

  • Secondary Outcome

    2 to 3 years

  • Co-Secondary Outcome

    2 to 3 years

Study Arms (1)

Critical Limb ischemia patients with tissue loss

CLI patients with minor and major tissue loss who had endovascular revascularisation

Procedure: Endovascular revascularisation

Interventions

Endovascular revascularisationPROCEDURE

Peripheral vascular angioplasty or stenting

Critical Limb ischemia patients with tissue loss

Eligibility Criteria

Age33 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are recruited from EWMSC, Trinidad who presented with CLI.

You may qualify if:

  • CLI patient with tissue loss who underwent infra inguinal endovascular limb salvage

You may not qualify if:

  • CLI patients with tissue loss who had surgical bypass CLI patients with no tissue loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eric Williams Medical Sciences Complex

Port of Spain, North Central, 00000, Trinidad and Tobago

Location

Related Publications (1)

  • Harnanan D, Parbhu S, Pran L, Baboolal I, Harnarayan P, Naraynsingh V, Seecheran N. Endovascular Revascularization and Outcomes of Critical Limb-Threatening Ischemia in Trinidad and Tobago: The EVENT Pilot Study-Challenges in a Limited-Resource, Caribbean Setting. Cardiol Ther. 2023 Sep;12(3):511-524. doi: 10.1007/s40119-023-00322-9. Epub 2023 Jun 17.

    PMID: 37329412DERIVED

MeSH Terms

Conditions

Peripheral Arterial DiseasePeripheral Vascular Diseases

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 21, 2022

Study Start

May 1, 2018

Primary Completion

May 1, 2021

Study Completion

May 1, 2022

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

TR(1)