Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL

Completed

• Conditions: Thoracic Diseases
• Interventions: Device: CTAG Device with ACTIVE CONTROL

• Registration Number: NCT03286400
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-18
• Study Start: 2017-10-18
• Primary Completion: 2019-10-09
• Study Completion: 2019-10-09
• Results First Submitted: 2020-10-23
• Results First Submitted QC: 2020-10-23
• Status Verified: 2020-11
• Results First Posted: 2020-11-17
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CTAG Device with ACTIVE CONTROL	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Procedural Technical Success	24 hours	Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion
Number of Subjects With Treatment Success at 30 Day Visit	One month	Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Freedom From Major Adverse Events at 12 Months	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
Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events	Days 30, 365, and 455	Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis.
Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion	One year	One year change from first post-implant CT scan in maximum aortic diameter
Change in Maximum Aortic Diameter Among Dissection	One year	One year change from first post-implant CT scan in maximum aortic diameter
Change in Minimum True Lumen Diameter Among Dissection	One year	One year change from first post-implant CT scan in minimum true lumen diameter
Number of Subjects With Freedom From Major Adverse Events at 30 Days	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
Change in Maximum False Lumen Diameter Among Dissection	One year	One year change from first post-implant CT scan in maximum false lumen diameter
Number of Subjects With Treatment Success at 12 Month Visit	One year	Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration

Trial Locations

Locations (20)

University of Heidelberg; 🇩🇪 Heidelberg, Germany

St. Franziskus Hospital GmbH; 🇩🇪 Münster, Germany

Hospital Civili Brescia; 🇮🇹 Brescia, Italy

Azienda Ospedaliers San Camilla Forlanni; 🇮🇹 Roma, Italy

Uppsala University; 🇸🇪 Uppsala, Sweden

Orebro University Hospital; 🇸🇪 Örebro, Sweden

University Hospital Angers; 🇫🇷 Angers, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

University Hospital Köln; 🇩🇪 Köln, Germany

University Hospital Regensburg; 🇩🇪 Regensburg, Germany

Ospedali dei Colli - Monaldi; 🇮🇹 Napoli, Italy

University Hospital Amsterdam; 🇳🇱 Amsterdam, Netherlands

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

St Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Hospital Clínico Santiago de Compostela; 🇪🇸 Santiago De Compostela, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

St Thomas' London / Guy's Hospital; 🇬🇧 London, United Kingdom

St George's Vascular Institute; 🇬🇧 London, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom