Status:
COMPLETED
Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Thoracic Diseases
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
This is an observational, prospective, single-arm, post-market registry designed to collect real-world clinical and device specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featurin...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Signed informed consent form
- Willingness, in the opinion of the investigator, to adhere to standard of care follow-up requirements
- Surgical indication for TEVAR based on investigator's best medical judgment
- Intent to treat with CTAG Device with ACTIVE CONTROL.
Exclusion
- Paraplegia or paraparesis at initial presentation
- Participation in concurrent research study or registry which may confound registry results, unless approved by Sponsor
- Prior implantation of a thoracic stent graft
- Pregnant or breast-feeding female at time of informed consent signature
- Life expectancy \< 1 year due to comorbidities
Key Trial Info
Start Date :
October 18 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 9 2019
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT03286400
Start Date
October 18 2017
End Date
October 9 2019
Last Update
December 17 2020
Active Locations (20)
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1
University Hospital Angers
Angers, France
2
CHU Strasbourg
Strasbourg, France
3
University Hospital Köln
Cologne, Germany
4
University of Heidelberg
Heidelberg, Germany