Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL

W.L.Gore & Associates127 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

127

Conditions

Thoracic Diseases

Interventions

CTAG Device with ACTIVE CONTROLDEVICE

Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

University Hospital Angers

Angers, France

CHU Strasbourg

Strasbourg, France

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: One month

Secondary Outcomes

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

Time frame: 30 Days

Number of Subjects With Freedom From Major Adverse Events at 12 Months

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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