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The British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair Registry

NCT03966521 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2023-03-24

No results posted yet for this study

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

Sponsors & Collaborators

  • The British Society of Endovascular Therapy (BSET)

    collaborator UNKNOWN

  • Imperial College London

    lead OTHER

Principal Investigators

  • Colin D Bicknell, MB MD FRCS · Imperial College London

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2022-03-20
Completion
2022-12-20

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03966521 on ClinicalTrials.gov