GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

NCT02266342 | Completed Results

• 1 other identifier: FPR12-03
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With All-cause Mortality (Long-term)

  5 years

Secondary Outcomes (7)

• Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture

  5 years

• Number of Subjects With Neurological Complications

  5 years

• Number of Subjects With Cardiac, Renal, and Pulmonary Complications

  5 years

• Number of Subjects With Device-related Complications

  5 years

• Number of Subjects With Surgical Conversion

  5 years

Interventions

GORE® TAG® Thoracic Endoprostheses DEVICE

Endovascular therapy to treat thoracic disease

Also known as: Conformable GORE® TAG® Thoracic Endoprostheses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with a disease of the descending thoracic aorta, requiring treatment with a thoracic endoprosthesis.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Dissection, Thoracic Aorta; Aortic Diseases; Penetrating Atherosclerotic Ulcer

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Dissection; Dissection, Blood Vessel; Acute Aortic Syndrome; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Charee Robe, Biostatistician
• Organization: W.L. Gore & Associates

crobe@wlgore.com

928-864-4048

Study Officials

• Nabil Chakfé, Prof

  Hôpitaux Universitaire de Strasbourg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 17, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: April 19, 2024
• Results First Posted: April 19, 2024

Record last verified: 2023-11

Locations

FR (1)