Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03966521
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2019-05-22
Brief Title:
The British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair Registry
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
The British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair BSET-CLEVAR Registry
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BSET-CLEVAR
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 fixationsealing 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 WL 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
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 fixationsealing 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 WL 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 keyholeor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRAS Project ID 260562 | OTHER | Health Research Authority | None |