BSET-CLEVAR: The British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair Registry
Study Details
Study Description
Brief 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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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
Outcome Measures
Primary Outcome Measures
- Endograft positioning accuracy and aortic neck coverage expressed as percentage of the total aortic neck assessed by CT images [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)
Secondary Outcome Measures
- Technical success defined as successful access and deployment of all required EXCC Device components [At the end of the primary procedure]
(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
- In-hospital mortality [During hospital admission for the primary EVAR procedure, to be reported for up to 12 months following the primary procedure]
Death occurring during hospital stay for EVAR
- Adjunct (supplementary) procedures received by the patient to resolve Type 1 endoleak on completion of EVAR [At the end of the primary EVAR procedure]
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)
- Freedom from Type 1 or 3 endoleak [At the end of the primary procedure; at first follow-up (between 4 weeks and 3 months); at second follow-up (1 year)]
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)
- One-year aneurysm-related re-intervention rate [One year after the primary procedure]
Any further aneurysm-related procedures that occur within 12 months following EVAR
- One-year aneurysm-related mortality [One year after the primary procedure]
Vital status of the patient one year after undergoing EVAR
Eligibility Criteria
Criteria
Inclusion Criteria:
The patient is / has:
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Age 55 or more at the time of informed consent signature.
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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).
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A signed and dated Informed Consent Form signed by the patient either before or within 30 days of EXCC device implantation
Exclusion Criteria:
The patient is / has:
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Previous infra-renal aortic surgery
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Been treated in another aortic or thoracic medical device study within 1 year of study enrollment.
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Active infection
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Penetrating aortic ulcer or dissection or intramural haematoma in the treated segment
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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
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In the opinion of the investigator unable or unwilling to comply with the requirements of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hull & East Yorkshire Hospitals NHS Trust (Hull Royal Infirmary) | Hull | East Yorkshire | United Kingdom | HU3 2JZ |
| 2 | Frimley Health NHS Foundation Trust | Frimley | Surrey | United Kingdom | GU16 7UJ |
| 3 | Imperial College Healthcare NHS Trust (St Mary's Hospital) | London | Westminster | United Kingdom | W2 1NY |
| 4 | NHS Grampian | Aberdeen | United Kingdom | AB25 2ZN | |
| 5 | Bedford Hospital NHS Trust | Bedford | United Kingdom | MK42 9DJ | |
| 6 | University Hospitals Dorset NHS Foundation Trust | Bournemouth | United Kingdom | BH7 7DW | |
| 7 | Cambridge University Hospitals NHS Foundation Trust | Cambridge | United Kingdom | CB2 0QQ | |
| 8 | Gloucestershire Hospitals NHS Foundation Trust | Cheltenham | United Kingdom | GL53 7AN | |
| 9 | NHS Tayside | Dundee | United Kingdom | ||
| 10 | Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom | LS1 3EX | |
| 11 | Liverpool University Hospitals NHS Foundation Trust | Liverpool | United Kingdom | ||
| 12 | Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom | SE1 7EH | |
| 13 | Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | United Kingdom |
Sponsors and Collaborators
- Imperial College London
- The British Society of Endovascular Therapy (BSET)
Investigators
- Principal Investigator: Colin D Bicknell, MB MD FRCS, Imperial College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19SM5135
- IRAS Project ID: 260562