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UnknownNCT05279274

ShorT Stay Aneurysm Repair Study

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
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Imperial College London · Academic / Other
Sex
All
Age
55 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2022-11-01
Primary completion
2023-12-31
Completion
2024-04-01
First posted
2022-03-15
Last updated
2022-08-05

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05279274. Inclusion in this directory is not an endorsement.