Trial Outcomes & Findings for GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta (NCT NCT00608829)

Last Updated: 2015-03-05

Results Overview

Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (\>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

one year

Results posted on

2015-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	45mm TAG Device Subjects The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true "line extension", as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
Overall Study STARTED	23
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	45mm TAG Device Subjects The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true "line extension", as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
Overall Study Death	6
Overall Study Withdrawal by Subject	4
Overall Study Subject refuses to follow up or return.	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	45mm TAG Device Subjects n=23 Participants The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true "line extension", as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
Age, Continuous	77.6 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Outcome measures

Outcome measures
Measure	45mm TAG Device Subjects n=23 Participants The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true "line extension", as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment	11 Participants

Adverse Events

45mm TAG Device Subjects

Serious events: 17 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	45mm TAG Device Subjects n=23 participants at risk The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true "line extension", as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
Blood and lymphatic system disorders Bleeding Complication	21.7% 5/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Cardiac disorders Cardiac Complication	26.1% 6/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Gastrointestinal disorders Bowel Complication	8.7% 2/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Infections and infestations Sepsis	8.7% 2/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Injury, poisoning and procedural complications Endoleak	13.0% 3/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Injury, poisoning and procedural complications Wound Complication	8.7% 2/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	4.3% 1/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Nervous system disorders Neurologic Complication	17.4% 4/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Renal and urinary disorders Genitourinary	8.7% 2/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Renal and urinary disorders Renal Function Complication	13.0% 3/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Respiratory, thoracic and mediastinal disorders Pulmonary Complication	21.7% 5/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Social circumstances Other Complication	34.8% 8/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Vascular disorders Vascular Complication	21.7% 5/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.

Other adverse events

Other adverse events
Measure	45mm TAG Device Subjects n=23 participants at risk The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true "line extension", as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
Blood and lymphatic system disorders Bleeding Complication	21.7% 5/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Cardiac disorders Cardiac Complication	34.8% 8/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Gastrointestinal disorders Bowel Complication	13.0% 3/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Injury, poisoning and procedural complications Endoleak	43.5% 10/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Injury, poisoning and procedural complications Wound Complication	8.7% 2/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Nervous system disorders Neurologic Complication	21.7% 5/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Renal and urinary disorders Genitourinary	13.0% 3/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Renal and urinary disorders Renal Function Complication	17.4% 4/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Respiratory, thoracic and mediastinal disorders Pulmonary Complication	39.1% 9/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Social circumstances Other Complication	52.2% 12/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
Vascular disorders Vascular Complication	8.7% 2/23 • Up to 5 years of follow-up Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.

Additional Information

Abe Letter

W.L. Gore and Associates

Phone: 928 864 3113

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Gore has the right to review disclosures, requesting a delay of more than 60 days but less than or equal to 180 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.
Publication restrictions are in place

Restriction type: OTHER