Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL

Thoracic Diseases Clinical Trial

— SURPASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286400
• Other study ID #: TAG 15-03
• Status: Completed
• Start date: October 18, 2017
• Est. completion date: October 9, 2019

Study information

• Verified date: November 2020
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: October 9, 2019
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Diseases

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion	One year change from first post-implant CT scan in maximum aortic diameter	One year
Secondary	Change in Maximum False Lumen Diameter Among Dissection	One year change from first post-implant CT scan in maximum false lumen diameter	One year
Secondary	Change in Minimum True Lumen Diameter Among Dissection	One year change from first post-implant CT scan in minimum true lumen diameter	One year
Secondary	Change in Maximum Aortic Diameter Among Dissection	One year change from first post-implant CT scan in maximum aortic diameter	One year