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Completed

NCT Number: NCT03286400

Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL

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.

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Key information

Conditions

Thoracic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTAG Device with ACTIVE CONTROL

Device

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

Primary outcomes

  1. Number of Subjects With Procedural Technical Success

    Time frame: 24 hours

    Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion

  2. Number of Subjects With Treatment Success at 30 Day Visit

    Time frame: One month

    Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration

Secondary outcomes

  1. Number of Subjects With Freedom From Major Adverse Events at 30 Days

    Time frame: 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

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

    Time frame: 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

  3. Number of Subjects With Treatment Success at 12 Month Visit

    Time frame: One year

    Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration

  4. Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events

    Time frame: Days 30, 365, and 455

    Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis.

  5. Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion

    Time frame: One year

    One year change from first post-implant CT scan in maximum aortic diameter

  6. Change in Maximum False Lumen Diameter Among Dissection

    Time frame: One year

    One year change from first post-implant CT scan in maximum false lumen diameter

  7. Change in Minimum True Lumen Diameter Among Dissection

    Time frame: One year

    One year change from first post-implant CT scan in minimum true lumen diameter

  8. Change in Maximum Aortic Diameter Among Dissection

    Time frame: One year

    One year change from first post-implant CT scan in maximum aortic diameter

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

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

Acronym: SURPASS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2017
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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