Endovascular Limb Salvage in Trinidad and Tobago

• Sponsor: Naveen Seecheran (Other)
• Overall Status: Completed
• CT.gov ID: NCT05547022
• Collaborator: (none)
• Enrollment: 157
• Location: 1
• Actual Duration (Months): 48
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Limb Salvage Rates With Endovascular Therapy	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 Design

• Study Type: Observational
• Actual Enrollment: 157 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Critical Limb Ischemia in Trinidad and Tobago- A Series of 157 Endovascular Limb Salvage Attempts in Patients With CLTI
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: May 1, 2021
• Actual Study Completion Date: May 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Primary outcome [2 to 3 years]

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

Other Outcome Measures

1. Secondary Outcome [2 to 3 years]

   to assess the maintenance of amputation free survival and bipedal ambulation

2. Co-Secondary Outcome [2 to 3 years]

   to evaluate primary patency rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 33 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eric Williams Medical Sciences Complex	Port Of Spain	North Central	Trinidad and Tobago	00000

Sponsors and Collaborators

• Naveen Seecheran

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Naveen Seecheran, MBBS (MD), MSc, FRCP(E), FACP, FACC, FESC, FSCAI, The University of The West Indies
• ClinicalTrials.gov Identifier: NCT05547022
• Other Study ID Numbers: CEC175/04/17
• First Posted: Sep 21, 2022
• Last Update Posted: Sep 21, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 21, 2022