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Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL (SURPASS)

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ClinicalTrials.gov Identifier: NCT03286400
Recruitment Status : Completed
First Posted : September 18, 2017
Results First Posted : November 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief 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.

Condition or disease Intervention/treatment
Thoracic Diseases Device: CTAG Device with ACTIVE CONTROL

Detailed 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 127 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG® Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System
Actual Study Start Date : October 18, 2017
Actual Primary Completion Date : October 9, 2019
Actual Study Completion Date : October 9, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients presenting with an indication for endovascular repair of the thoracic aorta are eligible for screening for participation in the registry. Only patients who meet all inclusion and no exclusion criteria, and who consent to participate will be enrolled.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286400


Locations
Show Show 20 study locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Giovanni Torsello, MD, PhD St Franziskus Hospital GmbH
  Study Documents (Full-Text)

Documents provided by W.L.Gore & Associates:
Study Protocol  [PDF] April 27, 2017
Statistical Analysis Plan  [PDF] June 6, 2019

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT03286400    
Other Study ID Numbers: TAG 15-03
First Posted: September 18, 2017    Key Record Dates
Results First Posted: November 17, 2020
Last Update Posted: December 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by W.L.Gore & Associates:
CTAG
TEVAR
Additional relevant MeSH terms:
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Thoracic Diseases
Respiratory Tract Diseases