SURPASS Registry
Research type
Research Study
Full title
Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System
IRAS ID
228157
Contact name
Bijan Modarai
Contact email
Sponsor organisation
W. L. Gore & Associates, Inc., Medical Products Division
Duration of Study in the UK
years, 30 months, 0 days
Research summary
The purpose of the study is to collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice.
The study will be conducted in up to 20 hospital sites in Europe with up to 125 patients, intended to be treated with CTAG Device with ACTIVE CONTROL. Approximately 36 patients will be recruited in the UK, 12 at each site.Patients will be enrolled into the registry providing all protocol inclusion/exclusion criteria are met. Following consent, participants will be evaluated through hospital discharge and at approximately 30 days after their procedure and at their first annual (approximately 12 months) follow up review. Additional follow up visits during this 12 month period will be conducted according to standard of care at each site and will be documented accordingly. The timings of the follow up evaluations are consistent with standard medical follow-up for patients who have undergone thoracic stent-graft.
REC name
London - Stanmore Research Ethics Committee
REC reference
17/LO/1296
Date of REC Opinion
25 Jul 2017
REC opinion
Favourable Opinion