STAR: ShorT Stay Aneurysm Repair Study

Sponsor

Imperial College London (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05279274

Collaborator

W.L.Gore & Associates (Industry), Medtronic (Industry)

100

Enrollment

Location

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm Without Rupture

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Outcome Measures

Primary Outcome Measures

Eligibility [12 months]
Proportion of patients suitable for a short stay pathway (assessed in 200 patients)
Uptake [12 months]
Proportion of patients who will accept admission to this pathway (assessed in all eligible patients)
Viability [12 months]
Proportion of patients admitted to the short-stay pathway that can be discharged at 23-hours
Treatment satisfaction [18 months]
Treatment satisfaction will be measured using the validated Aneurysm TSQ questionnaire
Patient well-being and stress [18 months]
Well-being (W-B16) questionnaires will be used to measure depressed and anxious mood, energy, positive well-being, and stress at baseline, at 2-4 days and 30 days post-op
Quality of life measure [18 months]
EQ-5D-5L health status questionnaires will be administered at baseline, 3- and 6-months post-op
Safety: Adverse events, readmissions and mortality [24 months]
Rate of device-related and other adverse events, readmission, mortality (at 30, 90 days and 6- and 12- months) of patients
Costs up to 6 months [18 months]
Inpatient micro-costing, surveys, as well as health resource use after discharged will be measured as any increase in social care and/or informal care

Secondary Outcome Measures

Qualitative data [12 months]
Describing the experiences, worries and concerns of patients, families and GPs as well as staff involved in the implementation of STAR, thus identifying the key barriers and drivers to implementation of a 23-hour pathway
Creation of a 'STAR tool-kit' [12 months]
This may be used for implementation of a short-stay pathway in a wider group, to ensure sustainability. The toolkit will be produced if there are a significant proportion eligible and accepting the pathway and the pathway is viable without perceived safety issues

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 Criteria:

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