NCT03286400

Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 127 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thoracic Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-18
• Primary completion: 2019-10-09
• Completion: 2019-10-09
• First posted: 2017-09-18
• Last updated: 2020-12-17
• Results posted: 2020-11-17

Locations

20 sites across 7 countries: France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom