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Completed

NCT Number: NCT05547022

Endovascular Limb Salvage in Trinidad and Tobago

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

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Key information

Conditions

Limb Salvage Rates With Endovascular Therapy Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

33 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eric Williams Medical Sciences Complex

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

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular revascularisation

Procedure

Peripheral vascular angioplasty or stenting

Primary outcomes

  1. Primary outcome

    Time frame: 2 to 3 years

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

Other outcomes

  1. Secondary Outcome

    Time frame: 2 to 3 years

    to assess the maintenance of amputation free survival and bipedal ambulation

  2. Co-Secondary Outcome

    Time frame: 2 to 3 years

    to evaluate primary patency rate

Sponsors and collaborators

Lead sponsor

Naveen Seecheran

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 21, 2022
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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