GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

Aortic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266342
• Other study ID #: FPR12-03
• Status: Completed
• Start date: October 2014
• Est. completion date: April 2022

Study information

• Verified date: November 2023
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: April 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aneurysm
• Aorta Thoracic; Traumatic Rupture
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Diseases
• Aortic Dissection
• Descending Thoracic Aortic Dissection
• Penetrating Ulcer
• Rupture

Intervention

Device:
• GORE® TAG® Thoracic Endoprostheses
Endovascular therapy to treat thoracic disease

Locations

Country	Name	City	State
France	Hopitaux Universitaire de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With All-cause Mortality (Long-term)		5 years
Secondary	Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture		5 years
Secondary	Number of Subjects With Neurological Complications		5 years
Secondary	Number of Subjects With Cardiac, Renal, and Pulmonary Complications		5 years
Secondary	Number of Subjects With Device-related Complications		5 years
Secondary	Number of Subjects With Surgical Conversion		5 years
Secondary	Number of Subjects With Secondary Procedures		5 years
Secondary	Number of Subjects With Disease Related Mortality		5 years