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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03286400
Other study ID # TAG 15-03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 18, 2017
Est. completion date October 9, 2019

Study information

Verified date November 2020
Source W.L.Gore & Associates
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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 disease as part of routine clinical practice.


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 featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice. A maximum of 20 clinical investigative sites in Europe will participate and up to 125 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the CTAG Device with ACTIVE CONTROL will be included and followed through one year per institutional standard of care.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date October 9, 2019
Est. primary completion date October 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age = 18 years 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: 1. Paraplegia or paraparesis at initial presentation 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
France University Hospital Angers Angers
France CHU Strasbourg Strasbourg
Germany University of Heidelberg Heidelberg
Germany University Hospital Köln Köln
Germany St. Franziskus Hospital GmbH Münster
Germany University Hospital Regensburg Regensburg
Italy Hospital Civili Brescia Brescia
Italy Ospedali dei Colli - Monaldi Napoli
Italy Azienda Ospedaliers San Camilla Forlanni Roma
Netherlands University Hospital Amsterdam Amsterdam
Netherlands St Antonius Hospital Nieuwegein
Netherlands Erasmus Medical Center Rotterdam
Spain Hospital Universitario Central de Asturias Oviedo
Spain Hospital Clínico Santiago de Compostela Santiago De Compostela
Spain Hospital Universitario Miguel Servet Zaragoza
Sweden Orebro University Hospital Örebro
Sweden Uppsala University Uppsala
United Kingdom Leeds General Infirmary Leeds
United Kingdom St George's Vascular Institute London
United Kingdom St Thomas' London / Guy's Hospital London

Sponsors (1)

Lead Sponsor Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects With Procedural Technical Success Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion 24 hours
Primary Number of Subjects With Treatment Success at 30 Day Visit Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration One month
Secondary Number of Subjects With Freedom From Major Adverse Events at 30 Days Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss 30 Days
Secondary Number of Subjects With Freedom From Major Adverse Events at 12 Months Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss 12 Months
Secondary Number of Subjects With Treatment Success at 12 Month Visit Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration One year
Secondary Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis. Days 30, 365, and 455
Secondary Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion One year change from first post-implant CT scan in maximum aortic diameter One year
Secondary Change in Maximum False Lumen Diameter Among Dissection One year change from first post-implant CT scan in maximum false lumen diameter One year
Secondary Change in Minimum True Lumen Diameter Among Dissection One year change from first post-implant CT scan in minimum true lumen diameter One year
Secondary Change in Maximum Aortic Diameter Among Dissection One year change from first post-implant CT scan in maximum aortic diameter One year
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