GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL

NCT03286400

Thoracic Diseases

COMPLETED

Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

NCT06507865

Aneurysm Dissection, Aortic TAA Thoracoabdominal Aortic Aneurysm +2 more

RECRUITING

Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms

NCT00590759

Aortic Aneurysm, Thoracic

COMPLETED NA

GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta

NCT00608829

Aortic Aneurysm, Thoracic

COMPLETED PHASE2

Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance

NCT06658730

Vascular Disease Dissection Dissection Aortic Aneurysm +5 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GORE® TAG® Thoracic Endoprostheses

Endovascular therapy to treat thoracic disease

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Conformable GORE® TAG® Thoracic Endoprostheses

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No