Endovascular Limb Salvage in Trinidad and Tobago

Critical Limb Ischemia in Trinidad and Tobago- A Series of 157 Endovascular Limb Salvage Attempts in Patients With CLTI

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

Study Overview

• Status: Completed
• Conditions: Limb Salvage Rates With Endovascular Therapy
• Intervention / Treatment: Procedure: Endovascular revascularisation

Detailed Description

A retrospective analytical study assessing limb salvage attempts and outcomes in 157 consecutive patients with CLI and tissue loss. It was for the period of May 2018 and May 2021 at Eric Williams Medical Sciences Complex.

The objectives of this study include Primary: To determine the success rate of target lesion revascularisation using endovascular limb salvage techniques in Critical limb ischemia patients with minor and major tissue loss.

Secondary objectives included:

1. to compare and contrast limb salvage rate to international standards
2. to assess the maintenance of amputation-free survival and bipedal ambulation
3. to evaluate the angiosome concept and its effect on wound healing
4. to evaluate primary patency rate
5. to assess the overall morbidity and mortality of endovascular treatment for critical limb ischemia
6. to observe the outcomes of various wound healing techniques and its efficacy

• Study Type: Observational
• Enrollment (Actual): 157

Contacts and Locations

Study Locations

• Trinidad and Tobago
  • North Central
    • Port Of Spain, North Central, Trinidad and Tobago, 00000
      • Eric Williams Medical Sciences Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critical Limb ischemia patients with tissue loss; CLI patients with minor and major tissue loss who had endovascular revascularisation	Procedure: Endovascular revascularisation; Peripheral vascular angioplasty or stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	to determine the success rate of target lesion revascularization using endovascular limb salvage techniques	2 to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome	to assess the maintenance of amputation free survival and bipedal ambulation	2 to 3 years
Co-Secondary Outcome	to evaluate primary patency rate	2 to 3 years

Collaborators and Investigators

• Sponsor: Naveen Seecheran

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Critical limb-threatening ischemia (CLTI); Endovascular revascularization (EVR); Peripheral arterial disease (PAD); Peripheral vascular disease (PVD).
• Other Study ID Numbers: CEC175/04/17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No