Clinical trial NCT03286400: Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
Official title: Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG® Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Diseases
Keywords: CTAG
TEVAR
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Subjects With Procedural Technical Success
timeFrame: 24 hours
measure: Number of Subjects With Treatment Success at 30 Day Visit
timeFrame: One month
Secondary outcomes:
measure: Number of Subjects With Freedom From Major Adverse Events at 30 Days
timeFrame: 30 Days
measure: Number of Subjects With Freedom From Major Adverse Events at 12 Months
timeFrame: 12 Months
measure: Number of Subjects With Treatment Success at 12 Month Visit
timeFrame: One year
measure: Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events
timeFrame: Days 30, 365, and 455
measure: Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion
timeFrame: One year
measure: Change in Maximum False Lumen Diameter Among Dissection
timeFrame: One year
measure: Change in Minimum True Lumen Diameter Among Dissection
timeFrame: One year
measure: Change in Maximum Aortic Diameter Among Dissection
timeFrame: One year
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital Angers
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Köln
country: Germany
facility: University Hospital Köln
city: Münster
country: Germany
facility: St. Franziskus Hospital GmbH
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Brescia
country: Italy
facility: Hospital Civili Brescia
city: Napoli
country: Italy
facility: Ospedali dei Colli - Monaldi
city: Roma
country: Italy
facility: Azienda Ospedaliers San Camilla Forlanni
city: Amsterdam
country: Netherlands
facility: University Hospital Amsterdam
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Santiago de Compostela
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Uppsala
country: Sweden
facility: Uppsala University
city: Örebro
country: Sweden
facility: Orebro University Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: St George's Vascular Institute
city: London
country: United Kingdom
facility: St Thomas' London / Guy's Hospital
Study officials:
affiliation: St Franziskus Hospital GmbH
name: Giovanni Torsello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.