Ignite Creation Date:
2024-05-06 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05279274
Status:
UNKNOWN
Last Update Posted:
2022-08-05
First Post:
2022-03-03
Brief Title:
ShorT Stay Aneurysm Repair Study
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
ShorT Stay Aneurysm Repair STAR A 23-hour Endovascular Abdominal Aortic Aneurysm Repair Pathway With Evaluation of Eligibility Uptake Viability Acceptability Safety and Cost
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief Summary:
A prospective observational cohort study to assess the eligibility uptake viability acceptability safety and cost of a ShorT stay 23-hour Aneurysm Repair STAR pathway Outcomes will be collected for up to 1 year
Detailed Description:
The STAR study is a prospective multicentre observational cohort study to assess the eligibility uptake viability acceptability safety and cost of a short stay 23-hour aneurysm pathway for infrarenal AAA patients
The study will take place at least at five sites in the United Kingdom Over a 12-month recruitment period all patients with AAA referred to or diagnosed at each of the units will be assessed for inclusion in the STAR pathway if suitable for EVAR The study anticipates the assessment of over 200 AAA patients with the aim of recruiting up to 100 patients into the study to undergo EVAR using the STAR pathway
Patients may be enrolled into the study to undergo EVAR using the STAR pathway provided all inclusion and no exclusion criteria are met Subjects will be evaluated through to hospital discharge receive a telephone call at 48 hours return for follow-up visits at one month and telephone follow-ups at three- and six months post treatment Patients recruited into the study will have their routine clinical data collected at 12 months when they return for follow-up visits
The study will take place at least at five sites in the United Kingdom Over a 12-month recruitment period all patients with AAA referred to or diagnosed at each of the units will be assessed for inclusion in the STAR pathway if suitable for EVAR The study anticipates the assessment of over 200 AAA patients with the aim of recruiting up to 100 patients into the study to undergo EVAR using the STAR pathway
Patients may be enrolled into the study to undergo EVAR using the STAR pathway provided all inclusion and no exclusion criteria are met Subjects will be evaluated through to hospital discharge receive a telephone call at 48 hours return for follow-up visits at one month and telephone follow-ups at three- and six months post treatment Patients recruited into the study will have their routine clinical data collected at 12 months when they return for follow-up visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRAS 302827 | OTHER | The Health Research Authority HRA | None |