The British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair Registry

NCT03966521 | Completed

• 2 other identifiers: 19SM5135IRAS Project ID: 260562
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 13

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.

Conditions

Abdominal Aortic Aneurysm Without Rupture

Keywords

Endovascular aneurysm repair

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  At the end of the primary procedure

• In-hospital mortality

  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

  At the end of the primary EVAR procedure

• 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)

• One-year aneurysm-related re-intervention rate

  One year after the primary procedure

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• The British Society of Endovascular Therapy (BSET): collaborator

Study Sites (13)

Hull & East Yorkshire Hospitals NHS Trust (Hull Royal Infirmary)

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Frimley Health NHS Foundation Trust

Frimley, Surrey, GU16 7UJ, United Kingdom

Location

Imperial College Healthcare NHS Trust (St Mary's Hospital)

London, Westminster, W2 1NY, United Kingdom

Location

NHS Grampian

Aberdeen, AB25 2ZN, United Kingdom

Location

Bedford Hospital NHS Trust

Bedford, MK42 9DJ, United Kingdom

Location

University Hospitals Dorset NHS Foundation Trust

Bournemouth, BH7 7DW, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Gloucestershire Hospitals NHS Foundation Trust

Cheltenham, GL53 7AN, United Kingdom

Location

NHS Tayside

Dundee, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3EX, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, United Kingdom

Location

Study Officials

• Colin D Bicknell, MB MD FRCS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 29, 2019
• Study Start: June 26, 2019
• Primary Completion: March 20, 2022
• Study Completion: December 20, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

GB (13)