Abdominal Aortic Aneurysm Without RuptureBSET-CLEVARNCT03966521
The British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair Registry
An observational study of Abdominal Aortic Aneurysm Without Rupture, run by Imperial College London at 13 sites in United Kingdom.
Trial summary
The purpose of the BSET-CLEVAR Registry is to collect device-specific performance outcomes of the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System (EXCC device) in routine clinical treatment of patients with abdominal aortic aneurysm in the UK. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm Without Rupture
- How many people
- 105 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- 26 Jun 2019to 20 Dec 2022
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with abdominal aortic aneurysm who are suitable for endovascular repair of their AAA and are either being considered for or have received treatment by endoprosthesis implantation as part of their routine care at a participating NHS hospital
Who may be able to join
- The patient is / has:
- Age 55 or more at the time of informed consent signature.
- Non-ruptured infra-renal AAA that requires treatment, and in the opinion of the Investigator, whose anatomy is adequate to receive or has already received the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System (EXCC device).
- A signed and dated Informed Consent Form signed by the patient either before or within 30 days of EXCC device implantation
Who cannot join
- The patient is / has:
- Previous infra-renal aortic surgery
- Been treated in another aortic or thoracic medical device study within 1 year of study enrollment.
- Active infection
- Penetrating aortic ulcer or dissection or intramural haematoma in the treated segment
- Any clinically significant medical condition, which in the opinion of the investigator, may interfere with the study results or reduce life expectancy to <2 years
- In the opinion of the investigator unable or unwilling to comply with the requirements of the study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United Kingdom13 sites
NHS Grampian
Aberdeen, AB25 2ZN
Bedford Hospital NHS Trust
Bedford, MK42 9DJ
University Hospitals Dorset NHS Foundation Trust
Bournemouth, BH7 7DW
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Gloucestershire Hospitals NHS Foundation Trust
Cheltenham, GL53 7AN
NHS Tayside
Dundee
Frimley Health NHS Foundation Trust
Frimley, Surrey, GU16 7UJ
Hull & East Yorkshire Hospitals NHS Trust (Hull Royal Infirmary)
Hull, East Yorkshire, HU3 2JZ
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX
Liverpool University Hospitals NHS Foundation Trust
Liverpool
Imperial College Healthcare NHS Trust (St Mary's Hospital)
London, Westminster, W2 1NY
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich
About this study
Official title: The British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair (BSET-CLEVAR) Registry
The purpose of the BSET-CLEVAR Registry is to collect device-specific performance outcomes of the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System (EXCC device) in routine clinical treatment of patients with abdominal aortic aneurysm in the UK.
The novel EXCC device is an evolution of an established device allowing active shaping to conform to the specific patient aortic neck anatomy, with more accurate deployment, potentially greater neck coverage and better long term fixation/sealing. This may translate to improved effectiveness of this device over time, reducing the need for any further procedures. The primary aim of this study is to assess the degree of neck coverage by the EXCC device.
The British Society of Endovascular Therapy (BSET) has received funds from the stent manufacturer (W.L. Gore \& Associates, Inc.) to conduct this study. BSET and the Sponsor (Imperial College London) have full responsibility for the design, conduct, analysis and reporting of the study.
Read the detailed description
An abdominal aortic aneurysm (AAA) is a 'bulge' caused by weakness of the wall of the aorta (main blood vessel) in the section that travels down through the abdomen. An AAA can grow to a large size over time and it may burst (rupture), causing life-threatening internal bleeding. The standard method to prevent the AAA from bursting is to re-line the aorta with an artificial piece of rigid tubing called a stent that has been covered with material. This is inserted through the blood vessels from the artery in the groin to stop the aneurysm from expanding and restore normal diameter of the aorta. This is commonly known as a 'keyhole'or minimally invasive approach called endovascular aneurysm repair (EVAR).
There have been many advances in stent-graft technology to improve the accuracy and effectiveness of the EVAR procedure. A new design of an existing stent-graft that is currently being used in patients in many hospitals is the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL (also known as EXCC Device). This new device allows the operator to shape the upper end of the device so that it may be placed into the aorta more accurately, conforming to the shape of the aorta, potentially improving the fixation and long-term sealing of the aneurysm, which may translate to a reduction in the need for further procedures.
This study is a prospective, multi-centre observational cohort registry of patients undergoing routine clinical treatment of AAA by the EXCC device. Recruitment will take place in 13 experienced UK centres with extensive EVAR experience. Up to 150 participants will be recruited in 30 months and followed-up to 1 year (participants will not undergo any procedure that is not part of their routine clinical care). Clinical data and device specific outcomes, including complications and re-interventions will be prospectively collected. In addition, the BSET-CLEVAR Registry Core Lab will evaluate both the pre-operative CT scan and the post-operative CT scan (obtained between 4 weeks and 3-months following EVAR), to assess the primary outcome of the study (endograft positioning accuracy and aortic neck coverage expressed as percentage of the total aortic neck assessed). Study outcomes will also include detailed analysis of pathological and anatomical features of the aneurysm and the EXCC device, which will be used for reporting the effectiveness of the graft. A detailed statistical analysis plan will be written prior to the final analysis.
The Study Co-ordinating Centre based at Imperial College London is responsible for the overall coordination of the Study, including monitoring of the overall study progress and review of study data accuracy (which, if necessary, may be checked by auditing the source data).
- Keywords
- Endovascular aneurysm repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Endograft positioning accuracy and aortic neck coverage expressed as percentage of the total aortic neck assessed by CT images
The median aortic neck surface area utilized will be calculated from pre- and post-operative CT images, which will be obtained between 4 weeks and 3 months following primary EVAR procedure (timing depends on local EVAR surveillance policy)
Measured: between 4 weeks and 3 months following EVAR
Secondary outcomes (6)
Technical success defined as successful access and deployment of all required EXCC Device components
(Yes/No) - Success defined as no type I/III endoleak, no conversion to open repair \& patient leaving theatre alive; to be assessed by the operating clinician on completion of EVAR
Measured: At the end of the primary procedure
In-hospital mortality
Death occurring during hospital stay for EVAR
Measured: During hospital admission for the primary EVAR procedure, to be reported for up to 12 months following the primary procedure
Adjunct (supplementary) procedures received by the patient to resolve Type 1 endoleak on completion of EVAR
Further steps (procedures) required to deal with type 1 endoleak (a failure of the first section of the stent-graft as it is fixed in the aorta below the renal arteries)
Measured: At the end of the primary EVAR procedure
Freedom from Type 1 or 3 endoleak
No type 1 endoleak (a failure of the first section of the stent-graft as it is fixed in the aorta below the renal arteries) or Type 3 endoleak (a failure of sealing of the components of the stent-graft)
Measured: At the end of the primary procedure; at first follow-up (between 4 weeks and 3 months); at second follow-up (1 year)
One-year aneurysm-related re-intervention rate
Any further aneurysm-related procedures that occur within 12 months following EVAR
Measured: One year after the primary procedure
One-year aneurysm-related mortality
Vital status of the patient one year after undergoing EVAR
Measured: One year after the primary procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start26 Jun 2019
- Primary completion20 Mar 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 105 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- The British Society of Endovascular Therapy (BSET)
- Responsible party
- Sponsor
- Investigators
- Colin D Bicknell, MB MD FRCS, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966521
- Sponsor's protocol ID
- 19SM5135
- Other IDs
- IRAS Project ID: 260562
- Acronym
- BSET-CLEVAR
- Status last verified
- Mar 2023
- First submitted
- 22 May 2019
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair (BSET-CLEVAR) Registry
- ClinicalTrials.gov ID
- NCT03966521
- Acronym / sponsor ID
- BSET-CLEVAR / 19SM5135
- Keywords
- Endovascular aneurysm repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- The British Society of Endovascular Therapy (BSET)
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 29 May 2019 (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.
The purpose of the BSET-CLEVAR Registry is to collect device-specific performance outcomes of the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System (EXCC device) in routine clinical treatment of patients with abdominal aortic aneurysm in the UK.
The novel EXCC device is an evolution of an established device allowing active shaping to conform to the specific patient aortic neck anatomy, with more accurate deployment, potentially greater neck coverage and better long term fixation/sealing. This may translate to improved effectiveness of this device over time, reducing the need for any further procedures. The primary aim of this study is to assess the degree of neck coverage by the EXCC device.
The British Society of Endovascular Therapy (BSET) has received funds from the stent manufacturer (W.L. Gore \& Associates, Inc.) to conduct this study. BSET and the Sponsor (Imperial College London) have full responsibility for the design, conduct, analysis and reporting of the study.
Detailed description
An abdominal aortic aneurysm (AAA) is a 'bulge' caused by weakness of the wall of the aorta (main blood vessel) in the section that travels down through the abdomen. An AAA can grow to a large size over time and it may burst (rupture), causing life-threatening internal bleeding. The standard method to prevent the AAA from bursting is to re-line the aorta with an artificial piece of rigid tubing called a stent that has been covered with material. This is inserted through the blood vessels from the artery in the groin to stop the aneurysm from expanding and restore normal diameter of the aorta. This is commonly known as a 'keyhole'or minimally invasive approach called endovascular aneurysm repair (EVAR).
There have been many advances in stent-graft technology to improve the accuracy and effectiveness of the EVAR procedure. A new design of an existing stent-graft that is currently being used in patients in many hospitals is the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL (also known as EXCC Device). This new device allows the operator to shape the upper end of the device so that it may be placed into the aorta more accurately, conforming to the shape of the aorta, potentially improving the fixation and long-term sealing of the aneurysm, which may translate to a reduction in the need for further procedures.
This study is a prospective, multi-centre observational cohort registry of patients undergoing routine clinical treatment of AAA by the EXCC device. Recruitment will take place in 13 experienced UK centres with extensive EVAR experience. Up to 150 participants will be recruited in 30 months and followed-up to 1 year (participants will not undergo any procedure that is not part of their routine clinical care). Clinical data and device specific outcomes, including complications and re-interventions will be prospectively collected. In addition, the BSET-CLEVAR Registry Core Lab will evaluate both the pre-operative CT scan and the post-operative CT scan (obtained between 4 weeks and 3-months following EVAR), to assess the primary outcome of the study (endograft positioning accuracy and aortic neck coverage expressed as percentage of the total aortic neck assessed). Study outcomes will also include detailed analysis of pathological and anatomical features of the aneurysm and the EXCC device, which will be used for reporting the effectiveness of the graft. A detailed statistical analysis plan will be written prior to the final analysis.
The Study Co-ordinating Centre based at Imperial College London is responsible for the overall coordination of the Study, including monitoring of the overall study progress and review of study data accuracy (which, if necessary, may be checked by auditing the source data).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with abdominal aortic aneurysm who are suitable for endovascular repair of their AAA and are either being considered for or have received treatment by endoprosthesis implantation as part of their routine care at a participating NHS hospital
Key inclusion criteria (4 listed)
- Age 55 or more at the time of informed consent signature.
- Non-ruptured infra-renal AAA that requires treatment, and in the opinion of the Investigator, whose anatomy is adequate to receive or has already received the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System (EXCC device).
- A signed and dated Informed Consent Form signed by the patient either before or within 30 days of EXCC device implantation
Key exclusion criteria (7 listed)
- Previous infra-renal aortic surgery
- Been treated in another aortic or thoracic medical device study within 1 year of study enrollment.
- Active infection
- Penetrating aortic ulcer or dissection or intramural haematoma in the treated segment
- Any clinically significant medical condition, which in the opinion of the investigator, may interfere with the study results or reduce life expectancy to <2 years
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
Endograft positioning accuracy and aortic neck coverage expressed as percentage of the total aortic neck assessed by CT images
Time frame: between 4 weeks and 3 months following EVAR
The median aortic neck surface area utilized will be calculated from pre- and post-operative CT images, which will be obtained between 4 weeks and 3 months following primary EVAR procedure (timing depends on local EVAR surveillance policy)
6 secondary outcomes
Technical success defined as successful access and deployment of all required EXCC Device components
Time frame: At the end of the primary procedure
In-hospital mortality
Time frame: During hospital admission for the primary EVAR procedure, to be reported for up to 12 months following the primary procedure
Adjunct (supplementary) procedures received by the patient to resolve Type 1 endoleak on completion of EVAR
Time frame: At the end of the primary EVAR procedure
Freedom from Type 1 or 3 endoleak
Time frame: At the end of the primary procedure; at first follow-up (between 4 weeks and 3 months); at second follow-up (1 year)
One-year aneurysm-related re-intervention rate
Time frame: One year after the primary procedure
One-year aneurysm-related mortality
Time frame: One year after the primary procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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 D Bicknell, MB MD FRCS principal investigator
Imperial College London
13 sites 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 13 sites 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endograft positioning accuracy and aortic neck coverage expressed as percentage of the total aortic neck assessed by CT images (time frame: between 4 weeks and 3 months following EVAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2023.