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

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ClinicalTrials.gov Identifier: NCT03286400
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : May 14, 2018
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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 125 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

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. 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. Treatment Success at One Month [ Time Frame: One month ]
    Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration


Secondary Outcome Measures :
  1. Freedom from Major Adverse Events through One Year [ Time Frame: One year ]
    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. Treatment Success at One Year [ Time Frame: One year ]
    Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration



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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


Contacts
Contact: KAREN I PARSONS +1 928 814 6692 kparsons@wlgore.com
Contact: Alexandre Figard +33 6 08 02 42 91 afigard@wlgore.com

Locations
France
University Hospital Angers Active, not recruiting
Angers, France
Germany
University of Heidelberg Recruiting
Heidelberg, Germany
Contact: Dittmar Bӧckler, MD         
University Hospital Köln Recruiting
Köln, Germany
Contact: Jan Brunkwall, MD, PhD         
St. Franziskus Hospital GmbH Recruiting
Münster, Germany
Contact: Giovanni Torsello, MD, PhD    +49 251 935 3933    giovanni.torsello@ukmuenster.de   
Sub-Investigator: Martin J Austermann, MD         
University Hospital Regensburg Recruiting
Regensburg, Germany
Contact: Karin Pfister, MD         
Italy
Hospital Civili Brescia Recruiting
Brescia, Italy
Contact: Stefano Bonardelli, MD         
Ospedali dei Colli - Monaldi Recruiting
Napoli, Italy
Contact: Giovanni Dialetto, MD         
Netherlands
University Hospital Amsterdam Recruiting
Amsterdam, Netherlands
Contact: Kakkhee Yeung, MD, PhD         
St Antonius Hospital Recruiting
Nieuwegein, Netherlands
Contact: Robin Heijmen, MD         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Hence Verhagen, MD, PhD         
Spain
Hospital Universitario Central de Asturias Active, not recruiting
Oviedo, Spain
Hospital Clínico Santiago de Compostela Active, not recruiting
Santiago De Compostela, Spain
Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain
Contact: José Lechón Saz, MD         
Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Anders Wanhainen, MD         
Örebro University Hospital Recruiting
Örebro, Sweden
Contact: Artai Pirouzram, MD         
United Kingdom
Leeds General Infirmary Active, not recruiting
Leeds, United Kingdom
St George's Vascular Institute Recruiting
London, United Kingdom
Contact: Ian Loftus, MD         
St Thomas' London / Guy's Hospital Recruiting
London, United Kingdom
Contact: Bijan Modarai, MD         
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Giovanni Torsello, MD, PhD St Franziskus Hospital GmbH

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT03286400     History of Changes
Other Study ID Numbers: TAG 15-03
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Thoracic Diseases
Respiratory Tract Diseases