ShorT Stay Aneurysm Repair Study (STAR)

August 4, 2022 updated by: Imperial College London

ShorT Stay Aneurysm Repair (STAR): A 23-hour Endovascular Abdominal Aortic Aneurysm Repair Pathway With Evaluation of Eligibility, Uptake, Viability, Acceptability, Safety and Cost

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with an infrarenal abdominal aortic aneurysm in at least five sites will be assessed for inclusion into the study. This is expected to be over 200 patients in five high-volume sites. From these patients, suitable patients will be able to be enrolled in the STAR pathway. The investigators expect approximately 100 patients to be enrolled from five UK centres.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eligibility
Time Frame: 12 months
Proportion of patients suitable for a short stay pathway (assessed in 200 patients)
12 months
Uptake
Time Frame: 12 months
Proportion of patients who will accept admission to this pathway (assessed in all eligible patients)
12 months
Viability
Time Frame: 12 months

Proportion of patients admitted to the short-stay pathway that can be discharged

at 23-hours
12 months
Treatment satisfaction
Time Frame: 18 months
Treatment satisfaction will be measured using the validated Aneurysm TSQ questionnaire
18 months
Patient well-being and stress
Time Frame: 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
18 months
Quality of life measure
Time Frame: 18 months
EQ-5D-5L health status questionnaires will be administered at baseline, 3- and 6-months post-op
18 months
Safety: Adverse events, readmissions and mortality
Time Frame: 24 months
Rate of device-related and other adverse events, readmission, mortality (at 30, 90 days and 6- and 12- months) of patients
24 months
Costs up to 6 months
Time Frame: 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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative data
Time Frame: 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
12 months
Creation of a 'STAR tool-kit'
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

W.L.Gore & Associates
Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

April 1, 2024

Study Registration Dates

First Submitted

March 3, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (ACTUAL)

March 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21SM7261
  • IRAS 302827 (OTHER: The Health Research Authority (HRA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abdominal Aortic Aneurysm Without Rupture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe