GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

Sponsor

W.L.Gore & Associates (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02266342

Collaborator

(none)

160

Enrollment

Location

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Thoracic Descending Thoracic Aortic Dissection Aortic Diseases Aorta Thoracic; Traumatic Rupture Penetrating Ulcer	Device: GORE® TAG® Thoracic Endoprostheses

Detailed Description

Endovascular therapy to treat thoracic disease seems to provide a plausible benefit compared to surgery in terms of operative mortality and severe morbidity. The French National Health Authority (HAS) requires a 5-year follow-up as part of the renewal of reimbursement for these endoprostheses in order to collect long-term follow-up data under real-life conditions of use.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

160 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation on the Treatment of Diseases of the Thoracic Aorta With the Thoracic Endoprosthesis GORE® TAG®

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Apr 1, 2022

Outcome Measures

Primary Outcome Measures

Rate of long term all-cause mortality [5 years]

Secondary Outcome Measures

Exclusion rate of aneurysm, penetrating aortic ulcer (PAU), false lumen or site of rupture [5 years]
Rate of neurological complications [5 years]
Rate of cardiac, renal, and pulmonary complications [5 years]
Rate of device-related complications [5 years]
Rate of surgical conversion [5 years]
Rate of secondary procedures [5 years]
Rate of disease related mortality [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient where a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis is implanted (successfully or not) for the treatment of disease of the descending thoracic aorta.
Patient who had previously consented to the collection and processing of personal medical data.
Patient older than 18 years at the time of treatment.

Exclusion Criteria:

Patients who have already received treatment with a thoracic endoprosthesis other than the GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis and for whom 'revision' or reintervention is required.
Patients whose clinical follow-up is not possible (i.e. patients who cannot return for control visits because they live abroad).