Abdominal Aortic Aneurysm Without RuptureSTARNCT05279274
ShorT Stay Aneurysm Repair Study
An observational study of Abdominal Aortic Aneurysm Without Rupture, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm Without Rupture
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2022to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London
London, W2 1NY
Colin Bicknell, +44 (0)20 3312 6428, colin.bicknell@imperial.ac.uk
About this study
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
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.
Read the 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.
- Keywords
- Abdominal aortic aneurysm, Day case, Endovascular aneurysm repair, Short stay
- Medical subject headings
- Aortic Aneurysm, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility
Proportion of patients suitable for a short stay pathway (assessed in 200 patients)
Measured: 12 months
Uptake
Proportion of patients who will accept admission to this pathway (assessed in all eligible patients)
Measured: 12 months
Viability
Proportion of patients admitted to the short-stay pathway that can be discharged
at 23-hours
Measured: 12 months
Treatment satisfaction
Treatment satisfaction will be measured using the validated Aneurysm TSQ questionnaire
Measured: 18 months
Patient well-being and stress
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
Measured: 18 months
Quality of life measure
EQ-5D-5L health status questionnaires will be administered at baseline, 3- and 6-months post-op
Measured: 18 months
Safety: Adverse events, readmissions and mortality
Rate of device-related and other adverse events, readmission, mortality (at 30, 90 days and 6- and 12- months) of patients
Measured: 24 months
Costs up to 6 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
Measured: 18 months
Secondary outcomes (2)
Qualitative data
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
Measured: 12 months
Creation of a 'STAR tool-kit'
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Nov 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic Aneurysm Without RuptureStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- W.L.Gore & Associates, Medtronic
- Responsible party
- Sponsor
- Investigators
- Colin Bicknell, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279274
- Sponsor's protocol ID
- 21SM7261
- Other IDs
- IRAS 302827
- Acronym
- STAR
- Status last verified
- Aug 2022
- First submitted
- 3 Mar 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8. doi: 10.1016/S0140-6736(04)16979-1.
PubMed 15351191Epstein D, Sculpher MJ, Powell JT, Thompson SG, Brown LC, Greenhalgh RM. Long-term cost-effectiveness analysis of endovascular versus open repair for abdominal aortic aneurysm based on four randomized clinical trials. Br J Surg. 2014 May;101(6):623-31. doi: 10.1002/bjs.9464. Epub 2014 Mar 24.
PubMed 24664537Brown LC, Powell JT, Thompson SG, Epstein DM, Sculpher MJ, Greenhalgh RM. The UK EndoVascular Aneurysm Repair (EVAR) trials: randomised trials of EVAR versus standard therapy. Health Technol Assess. 2012;16(9):1-218. doi: 10.3310/hta16090.
PubMed 22381040Shaw SE, Preece R, Stenson KM, De Bruin JL, Loftus IM, Holt PJE, Patterson BO. Short Stay EVAR is Safe and Cost Effective. Eur J Vasc Endovasc Surg. 2019 Mar;57(3):368-373. doi: 10.1016/j.ejvs.2018.10.008. Epub 2018 Nov 12.
PubMed 30442563Al-Zuhir N, Wong J, Nammuni I, Curran G, Tang T, Varty K. Selection, thirty day outcome and costs for short stay endovascular aortic aneurysm repair (SEVAR). Eur J Vasc Endovasc Surg. 2012 Jun;43(6):662-5. doi: 10.1016/j.ejvs.2012.02.031. Epub 2012 Mar 26.
PubMed 22456002Lachat ML, Pecoraro F, Mayer D, Guillet C, Glenck M, Rancic Z, Schmidt CA, Puippe G, Veith FJ, Bleyn J, Bettex D. Outpatient endovascular aortic aneurysm repair: experience in 100 consecutive patients. Ann Surg. 2013 Nov;258(5):754-8; discussion 758-9. doi: 10.1097/SLA.0b013e3182a617f1.
PubMed 24045449Krajcer Z, Ramaiah VG, Henao EA, Metzger DC, Nelson WK, Moursi MM, Rajasinghe HA, Al-Dallow R, Miller LE; LIFE Registry Investigators. Perioperative Outcomes From the Prospective Multicenter Least Invasive Fast-Track EVAR (LIFE) Registry. J Endovasc Ther. 2018 Feb;25(1):6-13. doi: 10.1177/1526602817747871. Epub 2017 Dec 18.
PubMed 29251207Block PC, Ockene I, Goldberg RJ, Butterly J, Block EH, Degon C, Beiser A, Colton T. A prospective randomized trial of outpatient versus inpatient cardiac catheterization. N Engl J Med. 1988 Nov 10;319(19):1251-5. doi: 10.1056/NEJM198811103191904.
PubMed 3185621Vaughan J, Gurusamy KS, Davidson BR. Day-surgery versus overnight stay surgery for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD006798. doi: 10.1002/14651858.CD006798.pub4.
PubMed 23904112Paton F, Chambers D, Wilson P, Eastwood A, Craig D, Fox D, Jayne D, McGinnes E. Initiatives to reduce length of stay in acute hospital settings: a rapid synthesis of evidence relating to enhanced recovery programmes. Southampton (UK): NIHR Journals Library; 2014 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK259855/
PubMed 25642551Scantling-Birch Y, Martin G, Balaji S, Trant J, Nordon I, Malina M, Riga C, Bicknell C. Examining the impact of psychological distress on short-term postoperative outcomes after elective endovascular aneurysm repair (EVAR). J Psychosom Res. 2021 Mar;142:110367. doi: 10.1016/j.jpsychores.2021.110367. Epub 2021 Jan 19.
PubMed 33503514Dhesi J. Improving outcomes in older people undergoing elective surgery. J R Coll Physicians Edinb. 2010 Dec;40(4):348-53. doi: 10.4997/jrcpe.2010.416.
PubMed 21254711Romaine J, Peach G, Thompson M, Hinchliffe RJ, Bradley C. Psychometric validation of three new condition-specific questionnaires to assess quality of life, symptoms and treatment satisfaction of patients with aortic aneurysm. J Patient Rep Outcomes. 2019 May 16;3(1):29. doi: 10.1186/s41687-019-0119-0.
PubMed 31098754Peach G, Romaine J, Wilson A, Holt PJ, Thompson MM, Hinchliffe RJ, Bradley C. Design of new patient-reported outcome measures to assess quality of life, symptoms and treatment satisfaction in patients with abdominal aortic aneurysm. Br J Surg. 2016 Jul;103(8):1003-11. doi: 10.1002/bjs.10181. Epub 2016 May 23.
PubMed 27214517Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof E, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Buller CE, Creager MA, Ettinger SM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Ornato JP, Page RL, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery); American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Rhythm Society; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society for Vascular Surgery. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. Circulation. 2007 Oct 23;116(17):e418-99. doi: 10.1161/CIRCULATIONAHA.107.185699. Epub 2007 Sep 27. No abstract available.
PubMed 17901357
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05279274
- Acronym / sponsor ID
- STAR / 21SM7261
- Keywords
- Abdominal aortic aneurysm, Day case, Endovascular aneurysm repair, Short stay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- W.L.Gore & Associates, Medtronic
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eligibility
Time frame: 12 months
Proportion of patients suitable for a short stay pathway (assessed in 200 patients)
Uptake
Time frame: 12 months
Proportion of patients who will accept admission to this pathway (assessed in all eligible patients)
Viability
Time frame: 12 months
Proportion of patients admitted to the short-stay pathway that can be discharged at 23-hours
Treatment satisfaction
Time frame: 18 months
Treatment satisfaction will be measured using the validated Aneurysm TSQ questionnaire
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
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
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
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
2 secondary outcomes
Qualitative data
Time frame: 12 months
Creation of a 'STAR tool-kit'
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Background: PubMed 15351191Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8. doi: 10.1016/S0140-6736(04)16979-1.
- Background: PubMed 24664537Epstein D, Sculpher MJ, Powell JT, Thompson SG, Brown LC, Greenhalgh RM. Long-term cost-effectiveness analysis of endovascular versus open repair for abdominal aortic aneurysm based on four randomized clinical trials. Br J Surg. 2014 May;101(6):623-31. doi: 10.1002/bjs.9464. Epub 2014 Mar 24.
- Background: PubMed 22381040Brown LC, Powell JT, Thompson SG, Epstein DM, Sculpher MJ, Greenhalgh RM. The UK EndoVascular Aneurysm Repair (EVAR) trials: randomised trials of EVAR versus standard therapy. Health Technol Assess. 2012;16(9):1-218. doi: 10.3310/hta16090.
- Background: PubMed 30442563Shaw SE, Preece R, Stenson KM, De Bruin JL, Loftus IM, Holt PJE, Patterson BO. Short Stay EVAR is Safe and Cost Effective. Eur J Vasc Endovasc Surg. 2019 Mar;57(3):368-373. doi: 10.1016/j.ejvs.2018.10.008. Epub 2018 Nov 12.
- Background: PubMed 22456002Al-Zuhir N, Wong J, Nammuni I, Curran G, Tang T, Varty K. Selection, thirty day outcome and costs for short stay endovascular aortic aneurysm repair (SEVAR). Eur J Vasc Endovasc Surg. 2012 Jun;43(6):662-5. doi: 10.1016/j.ejvs.2012.02.031. Epub 2012 Mar 26.
- Background: PubMed 24045449Lachat ML, Pecoraro F, Mayer D, Guillet C, Glenck M, Rancic Z, Schmidt CA, Puippe G, Veith FJ, Bleyn J, Bettex D. Outpatient endovascular aortic aneurysm repair: experience in 100 consecutive patients. Ann Surg. 2013 Nov;258(5):754-8; discussion 758-9. doi: 10.1097/SLA.0b013e3182a617f1.
- Background: PubMed 29251207Krajcer Z, Ramaiah VG, Henao EA, Metzger DC, Nelson WK, Moursi MM, Rajasinghe HA, Al-Dallow R, Miller LE; LIFE Registry Investigators. Perioperative Outcomes From the Prospective Multicenter Least Invasive Fast-Track EVAR (LIFE) Registry. J Endovasc Ther. 2018 Feb;25(1):6-13. doi: 10.1177/1526602817747871. Epub 2017 Dec 18.
- Background: PubMed 3185621Block PC, Ockene I, Goldberg RJ, Butterly J, Block EH, Degon C, Beiser A, Colton T. A prospective randomized trial of outpatient versus inpatient cardiac catheterization. N Engl J Med. 1988 Nov 10;319(19):1251-5. doi: 10.1056/NEJM198811103191904.
- Background: PubMed 23904112Vaughan J, Gurusamy KS, Davidson BR. Day-surgery versus overnight stay surgery for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD006798. doi: 10.1002/14651858.CD006798.pub4.
- Background: PubMed 25642551Paton F, Chambers D, Wilson P, Eastwood A, Craig D, Fox D, Jayne D, McGinnes E. Initiatives to reduce length of stay in acute hospital settings: a rapid synthesis of evidence relating to enhanced recovery programmes. Southampton (UK): NIHR Journals Library; 2014 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK259855/
- Background: PubMed 33503514Scantling-Birch Y, Martin G, Balaji S, Trant J, Nordon I, Malina M, Riga C, Bicknell C. Examining the impact of psychological distress on short-term postoperative outcomes after elective endovascular aneurysm repair (EVAR). J Psychosom Res. 2021 Mar;142:110367. doi: 10.1016/j.jpsychores.2021.110367. Epub 2021 Jan 19.
- Background: PubMed 21254711Dhesi J. Improving outcomes in older people undergoing elective surgery. J R Coll Physicians Edinb. 2010 Dec;40(4):348-53. doi: 10.4997/jrcpe.2010.416.
- The NHS Outcomes Framework 2013/14Link provided by the sponsor.
- Enhanced recovery care pathway: A better journey for patients seven days a week and better deal for the NHSLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Bicknell principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm Without Rupture, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colin Bicknell (02033126072, colin.bicknell@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05279274, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.