Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL (SURPASS)

W.L. Gore & Associates

Status: Completed

Conditions: Thoracic Diseases

Treatments: Device: CTAG Device with ACTIVE CONTROL

Study type: Observational

Funder types: Industry

Identifiers

NCT03286400

TAG 15-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

127 participants in 1 patient group

CTAG Device with ACTIVE CONTROL

Description:

All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.

Treatment:

Device: CTAG Device with ACTIVE CONTROL