Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
NCT ID: NCT03286400
Last Updated: 2020-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
127 participants
OBSERVATIONAL
2017-10-18
2019-10-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CTAG Device with ACTIVE CONTROL
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL
Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
Interventions
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CTAG Device with ACTIVE CONTROL
Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent form
3. Willingness, in the opinion of the investigator, to adhere to standard of care follow-up requirements
4. Surgical indication for TEVAR based on investigator's best medical judgment
5. Intent to treat with CTAG Device with ACTIVE CONTROL.
Exclusion Criteria
2. Participation in concurrent research study or registry which may confound registry results, unless approved by Sponsor
3. Prior implantation of a thoracic stent graft
4. Pregnant or breast-feeding female at time of informed consent signature
5. Life expectancy \< 1 year due to comorbidities
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Giovanni Torsello, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
St Franziskus Hospital GmbH
Locations
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University Hospital Angers
Angers, , France
CHU Strasbourg
Strasbourg, , France
University Hospital Köln
Cologne, , Germany
University of Heidelberg
Heidelberg, , Germany
St. Franziskus Hospital GmbH
Münster, , Germany
University Hospital Regensburg
Regensburg, , Germany
Hospital Civili Brescia
Brescia, , Italy
Ospedali dei Colli - Monaldi
Napoli, , Italy
Azienda Ospedaliers San Camilla Forlanni
Roma, , Italy
University Hospital Amsterdam
Amsterdam, , Netherlands
St Antonius Hospital
Nieuwegein, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Clínico Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Orebro University Hospital
Örebro, , Sweden
Uppsala University
Uppsala, , Sweden
Leeds General Infirmary
Leeds, , United Kingdom
St George's Vascular Institute
London, , United Kingdom
St Thomas' London / Guy's Hospital
London, , United Kingdom
Countries
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References
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Torsello GF, Argyriou A, Stavroulakis K, Bosiers MJ, Austermann M, Torsello GB; SURPASS Registry Collaborators. One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System. J Endovasc Ther. 2020 Jun;27(3):421-427. doi: 10.1177/1526602820913007. Epub 2020 Mar 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TAG 15-03
Identifier Type: -
Identifier Source: org_study_id