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

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

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Diseases
• Intervention / Treatment: 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
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• France
  • Angers, France
    • University Hospital Angers
  • Strasbourg, France
    • CHU Strasbourg
• Germany
  • Heidelberg, Germany
    • University of Heidelberg
  • Köln, Germany
    • University Hospital Köln
  • Münster, Germany
    • St. Franziskus Hospital GmbH
  • Regensburg, Germany
    • University Hospital Regensburg
• Italy
  • Brescia, Italy
    • Hospital Civili Brescia
  • Napoli, Italy
    • Ospedali dei Colli - Monaldi
  • Roma, Italy
    • Azienda Ospedaliers San Camilla Forlanni
• Netherlands
  • Amsterdam, Netherlands
    • University Hospital Amsterdam
  • Nieuwegein, Netherlands
    • St Antonius hospital
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• Spain
  • Oviedo, Spain
    • Hospital Universitario Central de Asturias
  • Santiago De Compostela, Spain
    • Hospital Clínico Santiago de Compostela
  • Zaragoza, Spain
    • Hospital Universitario Miguel Servet
• Sweden
  • Uppsala, Sweden
    • Uppsala University
  • Örebro, Sweden
    • Orebro University Hospital
• United Kingdom
  • Leeds, United Kingdom
    • Leeds General Infirmary
  • London, United Kingdom
    • St George's Vascular Institute
  • London, United Kingdom
    • St Thomas' London / Guy's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Giovanni Torsello, MD, PhD, St Franziskus Hospital GmbH

Publications and helpful links

General Publications

• Torsello GF, Argyriou A, Stavroulakis K, Bosiers MJ, Austermann M, Torsello GB; SURPASS Registry Collaborators. One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System. J Endovasc Ther. 2020 Jun;27(3):421-427. doi: 10.1177/1526602820913007. Epub 2020 Mar 20.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2017
• Primary Completion (Actual): October 9, 2019
• Study Completion (Actual): October 9, 2019

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: TEVAR; CTAG
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Thoracic Diseases
• Other Study ID Numbers: TAG 15-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No