Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL

NCT03286400 | Completed Results DMC

• 1 other identifier: TAG 15-03
• Study Type: observational
• Target: 127
• Locations: 7 countries
• Sites: 20

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.

Conditions

Thoracic Diseases

Keywords

CTAG; TEVAR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Number of Subjects With Freedom From Major Adverse Events at 30 Days

  30 Days

• Number of Subjects With Freedom From Major Adverse Events at 12 Months

  12 Months

• Number of Subjects With Treatment Success at 12 Month Visit

  One year

• Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events

  Days 30, 365, and 455

• Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion

  One year

Study Arms (1)

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

Interventions

CTAG Device with ACTIVE CONTROL DEVICE

Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.

CTAG Device with ACTIVE CONTROL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years
• Signed informed consent form
• Willingness, in the opinion of the investigator, to adhere to standard of care follow-up requirements
• Surgical indication for TEVAR based on investigator's best medical judgment
• Intent to treat with CTAG Device with ACTIVE CONTROL.

You may not qualify if:

• Paraplegia or paraparesis at initial presentation
• Participation in concurrent research study or registry which may confound registry results, unless approved by Sponsor
• Prior implantation of a thoracic stent graft
• Pregnant or breast-feeding female at time of informed consent signature
• Life expectancy \< 1 year due to comorbidities

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (20)

University Hospital Angers

Angers, France

Location

CHU Strasbourg

Strasbourg, France

Location

University Hospital Köln

Cologne, Germany

Location

University of Heidelberg

Heidelberg, Germany

Location

St. Franziskus Hospital GmbH

Münster, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

Hospital Civili Brescia

Brescia, Italy

Location

Ospedali dei Colli - Monaldi

Napoli, Italy

Location

Azienda Ospedaliers San Camilla Forlanni

Roma, Italy

Location

University Hospital Amsterdam

Amsterdam, Netherlands

Location

St Antonius Hospital

Nieuwegein, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Clínico Santiago de Compostela

Santiago de Compostela, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Orebro University Hospital

Örebro, Sweden

Location

Uppsala University

Uppsala, Sweden

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

St George's Vascular Institute

London, United Kingdom

Location

St Thomas' London / Guy's Hospital

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32193990 DERIVED

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

• Title: Eric Novak
• Organization: W. L. Gore & Associates

enovak@wlgore.com

314-440-2119

Study Officials

• Giovanni Torsello, MD, PhD

  St Franziskus Hospital GmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: October 18, 2017
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: December 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); GB (3); FR (2); ES (3); NL (3); SE (2); DE (4)