BSET-CLEVAR Registry

The British Society of Endovascular Therapy -ConformabLe EndoVascular Aneurysm Repair Registry

IRAS Project ID: 260562
Favourable ethical opinion given by the South East Scotland Research Ethics Committee (REC) 01 on 15th May 2019 (REC reference: 19/SS/0067)

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BSET-CLEVAR Study Protocol

Participating NHS Trusts

Information for patients and the public

Plain language (lay) summary of study results

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Study summary

Design: A prospective, multi-centre, observational cohort study of patients treated with the GORE EXCLUDER Conformable AAA Endoprosthesis with ACTIVE CONTROL System (EXCC Device)

Aims: The primary objective is to collect real-world clinical data and device-specific outcomes of EXCC Device in routine clinical treatment of patients with abdominal aortic aneurysm (AAA)

Methods: Prior to study-specific screening, all patients will have had a CT scan as part of their routine care and they will have been identified for routine treatment of their AAA by EVAR after meeting accepted surgical threshold criteria.  These patients will then be screened for potential inclusion in the BSET-CLEVAR registry by review of their medical notes by vascular clinicians from the patient's existing clinical care team, during the vascular multidisciplinary team (MDT) meeting, or in person during a routine appointment at the Vascular Out-patients clinic at the participating hospital.  If deemed suitable, the patient will be provided with study-specific patient information sheet (PIS) by their Vascular Surgeon or Vascular Specialist Nurse, either in person during a routine appointment (in which case they will be given a minimum of 24 hours to consider participating in the registry), or by post prior to their routine appointment.  They will have the opportunity to discuss the information contained in the PIS with their Vascular Surgeon/Vascular Specialist nurse and asked to consider participating in the registry.  

Written consent will be obtained from those patients who agree to participate and they will be assigned a study ID number.  Only patients who meet all of the inclusion criteria and none of the exclusion criteria specified below will be enrolled.  At each participating hospital, a log of all screened patients will be kept locally, which will record basic demographic data and reasons for non-eligibility.

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Outcome measures 

The primary outcome is the evaluation of positioning accuracy and aortic neck coverage expressed as a percentage of the total aortic neck assessed by CT scan between 4 weeks and 3 months follow-up*

Secondary outcome measures include:

• Technical success, defined as successful access and deployment of all required EXCC Device components
• In-hospital mortality
• Adjuncts to deal with type 1 endoleak at primary procedure
• Freedom from type 1 or type 3 endoleak at the end of procedure, by 3* months and 1* year
• 1-year aneurysm-related re-intervention rates
• 1-year aneurysm-related mortality

* Timelines for the first and final follow-up are flexible: First follow-up, including CT scan imaging, may be carried out between 4 weeks and 3 months and second (final) follow-up, including either a CT scan or duplex U/S imaging (depending on local EVAR surveillance policy), may be done at 12 months ± 4 weeks. 

Study size and setting: Up to 200 patients presenting with AAA to the study centres  (approximately 20 NHS hospitals in the United Kingdom) over a 12-month period.

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Eligibility

Inclusion Criteria

• Indication for aortic endovascular stent graft repair as determined by the treating physician. 
• 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 GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System
  • An Informed Consent Form dated and signed by the Subject.

Exclusion Criteria

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.

Duration: 12-month recruitment followed by 12-month follow-up

Funder: The British Society of Endovascular Therapy (BSET) has received funds from W.L. Gore & Associates, Inc. to carry out this perspective, investigator-initiated study.  BSET and the Sponsor (Imperial College London) will have full responsibility for the conduct of the study.