Trial Outcomes & Findings for GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry (NCT NCT02266342)

NCT ID: NCT02266342

Last Updated: 2024-04-19

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 154 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2024-04-19

Participant Flow

Participant milestones

Measure	GORE® TAG® Thoracic Endoprothesis Patients receiving a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis implant for the treatment of a descending thoracic aortic disease.
Overall Study STARTED	154
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	94

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	GORE® TAG® Thoracic Endoprothesis n=154 Participants Patients receiving a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis implant for the treatment of a descending thoracic aortic disease.
Age, Continuous	68 years n=154 Participants
Sex: Female, Male Female	49 Participants n=154 Participants
Sex: Female, Male Male	105 Participants n=154 Participants
Region of Enrollment France	154 participants n=154 Participants
Main Indication for Implantation Thoracic Aortic Aneurysm	56 Participants n=154 Participants
Main Indication for Implantation Type B Dissection of the Thoracic Aorta	60 Participants n=154 Participants
Main Indication for Implantation Traumatic Wound	15 Participants n=154 Participants
Main Indication for Implantation Penetrating Aortic Ulcer	17 Participants n=154 Participants
Main Indication for Implantation Other	6 Participants n=154 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Measure	GORE® TAG® Thoracic Endoprothesis n=154 Participants Patients receiving a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis implant for the treatment of a descending thoracic aortic disease.
Number of Subjects With All-cause Mortality (Long-term)	31 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Subjects with known exclusion status at 5 years with the following main indications for implantation: Thoracic Aortic Aneurysm, Type B Dissection of the Thoracic Aorta, Traumatic Wound, or Penetrating Aortic Ulcer

Outcome measures

Measure	GORE® TAG® Thoracic Endoprothesis n=64 Participants Patients receiving a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis implant for the treatment of a descending thoracic aortic disease.
Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture	50 Participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	GORE® TAG® Thoracic Endoprothesis n=154 Participants Patients receiving a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis implant for the treatment of a descending thoracic aortic disease.
Number of Subjects With Neurological Complications	13 Participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	GORE® TAG® Thoracic Endoprothesis n=154 Participants Patients receiving a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis implant for the treatment of a descending thoracic aortic disease.
Number of Subjects With Cardiac, Renal, and Pulmonary Complications	32 Participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	GORE® TAG® Thoracic Endoprothesis n=154 Participants Patients receiving a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis implant for the treatment of a descending thoracic aortic disease.
Number of Subjects With Device-related Complications	8 Participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	GORE® TAG® Thoracic Endoprothesis n=154 Participants Patients receiving a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis implant for the treatment of a descending thoracic aortic disease.
Number of Subjects With Surgical Conversion	0 Participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	GORE® TAG® Thoracic Endoprothesis n=154 Participants Patients receiving a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis implant for the treatment of a descending thoracic aortic disease.
Number of Subjects With Secondary Procedures	27 Participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	GORE® TAG® Thoracic Endoprothesis n=154 Participants Patients receiving a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis implant for the treatment of a descending thoracic aortic disease.
Number of Subjects With Disease Related Mortality	5 Participants

Adverse Events

GORE® TAG® Thoracic Endoprothesis

Serious events: 79 serious events

Other events: 38 other events

Deaths: 31 deaths

Serious adverse events

Measure	GORE® TAG® Thoracic Endoprothesis n=154 participants at risk GORE® TAG® and Conformable GORE® TAG® Thoracic Endoprosthesis Registiry conducted for reimbursement in France and no MedDRA coding was required.
Cardiac disorders Cardiac	8.4% 13/154 • Five year follow-up
Nervous system disorders Neurological	7.8% 12/154 • Five year follow-up
Respiratory, thoracic and mediastinal disorders Pulmonary	7.8% 12/154 • Five year follow-up
Renal and urinary disorders Renal	3.9% 6/154 • Five year follow-up
Vascular disorders Vascular	26.0% 40/154 • Five year follow-up
General disorders Other	15.6% 24/154 • Five year follow-up

Other adverse events

Measure	GORE® TAG® Thoracic Endoprothesis n=154 participants at risk GORE® TAG® and Conformable GORE® TAG® Thoracic Endoprosthesis Registiry conducted for reimbursement in France and no MedDRA coding was required.
Vascular disorders Vascular	15.6% 24/154 • Five year follow-up
Cardiac disorders Cardiac	3.2% 5/154 • Five year follow-up
Nervous system disorders Neurological	1.3% 2/154 • Five year follow-up
Renal and urinary disorders Renal	1.3% 2/154 • Five year follow-up
Respiratory, thoracic and mediastinal disorders Pulmonary	2.6% 4/154 • Five year follow-up
General disorders Other	3.2% 5/154 • Five year follow-up

Additional Information

Charee Robe, Biostatistician

W.L. Gore & Associates

Phone: 928-864-4048

Email: crobe@wlgore.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place