Endovascular Limb Salvage in Trinidad and Tobago | NCT05547022

Studies
Endovascular Limb Salvage in Trinidad and Tobago

NCT05547022

Sponsor

Naveen Seecheran

Status

Completed

Last Update Posted

Aug 25, 2023Actual

Enrollment

157Actual

Phase

Not provided

Conditions

Limb Salvage Rates With Endovascular Therapy

Interventions

Endovascular revascularisation

Countries

Trinidad and Tobago

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

May 1, 2021Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Sep 15, 2022

First Submission Date that Met QC Criteria

Sep 15, 2022

First Posted Date

Sep 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2023

Last Update Posted Date

Aug 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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:

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

157Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Critical Limb ischemia patients with tissue loss		CLI patients with minor and major tissue loss who had endovascular revascularisation	Procedure: Endovascular revascularisation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endovascular revascularisation	Procedure	Peripheral vascular angioplasty or stenting	Critical Limb ischemia patients with tissue loss

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

33 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eric Williams Medical Sciences Complex		Port of Spain	North Central	00000	Trinidad and Tobago

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37329412	Derived	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.

ID	Term
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases