Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG® Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System

Conditions
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Thoracic Diseases

Intervention / Treatment
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* Device: CTAG Device with ACTIVE CONTROL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CTAG Device with ACTIVE CONTROL<br>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL. | Device: CTAG Device with ACTIVE CONTROL<br>* Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion | One year change from first post-implant CT scan in maximum aortic diameter | One year | 
| Change in Maximum False Lumen Diameter Among Dissection | One year change from first post-implant CT scan in maximum false lumen diameter | One year | 
| Change in Minimum True Lumen Diameter Among Dissection | One year change from first post-implant CT scan in minimum true lumen diameter | One year | 
| Change in Maximum Aortic Diameter Among Dissection | One year change from first post-implant CT scan in maximum aortic diameter | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTAG, TEVAR