Status:
UNKNOWN
ShorT Stay Aneurysm Repair Study
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
W.L.Gore & Associates
Medtronic
Conditions:
Abdominal Aortic Aneurysm Without Rupture
Eligibility:
All Genders
55+ years
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 collec...
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 infr...
Eligibility Criteria
Inclusion
- They have been assessed as suitable for standard infrarenal EVAR within the manufacturer's "Instructions for Use" for the chosen endograft.
- Age over 55 (effectively excluding connective tissue disease)
- Fully independent at home or adequate provision for home care after discharge which would enable patients to perform basic activities of daily living including mobility, eating, drinking, and bathing
- Living with a partner or family member or having similar help available for the first 24-hours after discharge from the hospital
- Transport to attend the hospital in which they were treated within 1 hour for the first 24-hours after discharge. Should an ambulance not be readily available to attend the hospital within this timeframe, patients must be made aware and agree to make their own transport arrangements.
- Capable of complying with Protocol requirements, including follow-up
- An Informed Consent Form signed by the participant or legal representative
Exclusion
- Significant cardiac disease, defined as one or more major predictors of increased perioperative cardiovascular risk according to the American College of Cardiology Cardiac Risk Classification, which remains untreated at the time of surgery
- Significant renal failure (pre-operative creatinine level of over 150 μmol/L or GFR less than 30mL/min/1.73m2 indicating severe chronic kidney disease (stage IV)
- Significant respiratory disease needing increased post-operative care not available in the home environment (e.g., nebulisers or oxygen therapy which is not set up at home)
- Any other condition, which in the opinion of the multidisciplinary team makes discharge within 23-hours unsafe
- Patients who lack capacity to consent to 23-hour EVAR will be excluded from the study
- There is concurrent enrolment in another drug or medical device study or have recently been involved in any research prior to recruitment
Key Trial Info
Start Date :
November 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05279274
Start Date
November 1 2022
End Date
April 1 2024
Last Update
August 5 2022
Active Locations (1)
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1
Imperial College London
London, United Kingdom, W2 1NY