Limb Salvage Rates With Endovascular TherapyNCT05547022
Endovascular Limb Salvage in Trinidad and Tobago
An observational study of Limb Salvage Rates With Endovascular Therapy, run by Naveen Seecheran at 1 site in Trinidad and Tobago.
Trial summary
The purpose of this study was to investigate limb salvage rates in patients with critical limb ischemia after endovascular revascularization. Read more about this study
- Who is it for?
- Ages 33 to 89 years
- Conditions the study is for
- Limb Salvage Rates With Endovascular Therapy
- What is being tested?
- Endovascular revascularisation
- Type of treatment
- Surgery or procedure
- How many people
- 157 participants
- Where
- 1 siteTrinidad and Tobago
- Study dates
- 1 May 2018to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are recruited from EWMSC, Trinidad who presented with CLI.
Who may be able to join
- CLI patient with tissue loss who underwent infra inguinal endovascular limb salvage
Who cannot join
- CLI patients with tissue loss who had surgical bypass CLI patients with no tissue loss
Trial locations and contacts
1 site in 1 country.
Trinidad and Tobago1 site
Eric Williams Medical Sciences Complex
Port of Spain, North Central, 00000
About this study
Official title: 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.
Read the 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
- Being tested
- Endovascular revascularisation
- Keywords
- Critical limb-threatening ischemia (CLTI); Endovascular revascularization (EVR); Peripheral arterial disease (PAD); Peripheral vascular disease (PVD).
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular revascularisationProcedure or surgery
Peripheral vascular angioplasty or stenting
| Study group | Role | What they receive |
|---|---|---|
| Critical Limb ischemia patients with tissue loss | CLI patients with minor and major tissue loss who had endovascular revascularisation Receives: Procedure: Endovascular revascularisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
to determine the success rate of target lesion revascularization using endovascular limb salvage techniques
Measured: 2 to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 May 2018
- Primary completion1 May 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Limb Salvage Rates With Endovascular TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naveen Seecheran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naveen Seecheran, The University of The West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547022
- Sponsor's protocol ID
- CEC175/04/17
- Status last verified
- Aug 2023
- First submitted
- 15 Sep 2022
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37329412
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Limb Ischemia in Trinidad and Tobago- A Series of 157 Endovascular Limb Salvage Attempts in Patients With CLTI
- ClinicalTrials.gov ID
- NCT05547022
- Acronym / sponsor ID
- CEC175/04/17
- Keywords
- Critical limb-threatening ischemia (CLTI); Endovascular revascularization (EVR); Peripheral arterial disease (PAD); Peripheral vascular disease (PVD).
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Naveen SeecheranUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical Limb ischemia patients with tissue loss | – | Procedure: Endovascular revascularisationCLI patients with minor and major tissue loss who had endovascular revascularisation |
Who may qualify
- Ages
- 33 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited from EWMSC, Trinidad who presented with CLI.
Key inclusion criteria (1 listed)
- CLI patient with tissue loss who underwent infra inguinal endovascular limb salvage
Key exclusion criteria (1 listed)
- CLI patients with tissue loss who had surgical bypass CLI patients with no tissue loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular revascularisationPeripheral vascular angioplasty or stenting | Procedure or surgery | Critical Limb ischemia patients with tissue loss |
Primary outcome
Primary outcome
Time frame: 2 to 3 years
to determine the success rate of target lesion revascularization using endovascular limb salvage techniques
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Derived from this study: PubMed 37329412Harnanan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Salvage Rates With Endovascular Therapy, run by Naveen Seecheran at 1 site in Trinidad and Tobago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Trinidad and Tobago. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 2 to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05547022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.