Trial Outcomes & Findings for To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease (NCT NCT00757003)

NCT ID: NCT00757003

Last Updated: 2017-03-01

Results Overview

The percentage of participants with technically successful implantation as assessed by the investigator is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 100 participants
• Primary outcome timeframe: Day 0 to Day 30
• Results posted on: 2017-03-01

Participant Flow

Enrollment October 2000 - November 2007. Patients presenting or transferred to Stanford University Medical Center with thoracic aortic pathology deemed prohibitively high risk for open surgical repair.

Participant milestones

Measure	Treatment Arm - Placement of TAG Device Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Overall Study STARTED	100
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	49

Reasons for withdrawal

Measure	Treatment Arm - Placement of TAG Device Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Overall Study Death	33
Overall Study Lost to Follow-up	9
Overall Study Withdrawal by Subject	4
Overall Study Surgically explanted	2
Overall Study Not implanted	1

Baseline Characteristics

To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease

Baseline characteristics by cohort

Measure	Treatment Arm - Placement of TAG Device n=100 Participants Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Age, Continuous	64.4 years STANDARD_DEVIATION 17.4 • n=93 Participants
Gender Female	31 Participants n=93 Participants
Gender Male	69 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 30

The percentage of participants with technically successful implantation as assessed by the investigator is reported.

Outcome measures

Measure	Treatment Arm - Placement of TAG Device n=100 Participants Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Percentage of Participants With Technically Successful Implant	99.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 60 months following procedure

Endoleak is persistent blood flow in the aneurysm sac.

Outcome measures

Measure	Treatment Arm - Placement of TAG Device n=100 Participants Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Count of Participants Experiencing at Least One Endoleak Following Procedure	32 Participants

SECONDARY outcome

Timeframe: 60 months

Population: 9 lost to followup, 4 withdrew, 2 explanted, 1 never implanted, all excluded

Overall survival is reported as the count of participants alive 60 months following implant procedure.

Outcome measures

Measure	Treatment Arm - Placement of TAG Device n=84 Participants Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Overall Survival	51 Participants

Adverse Events

Treatment Arm - Placement of TAG Device

Serious events: 43 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Arm - Placement of TAG Device n=100 participants at risk A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta
Respiratory, thoracic and mediastinal disorders Atelectasis/Pneumonia	28.0% 28/100 • Number of events 28
Cardiac disorders cardiac arrhythmia	21.0% 21/100 • Number of events 21
Respiratory, thoracic and mediastinal disorders respiratory failure	13.0% 13/100 • Number of events 13
Respiratory, thoracic and mediastinal disorders pulmonary embolism	12.0% 12/100 • Number of events 12
Nervous system disorders change in mental status	11.0% 11/100 • Number of events 11
Nervous system disorders cerebrovascular accident	8.0% 8/100 • Number of events 8
Renal and urinary disorders renal failure	9.0% 9/100 • Number of events 9
Renal and urinary disorders renal insufficiency	7.0% 7/100 • Number of events 7
Surgical and medical procedures procedural hemorrhage	12.0% 12/100 • Number of events 12
Nervous system disorders paraplegia/paraparesis	1.0% 1/100 • Number of events 1
Surgical and medical procedures type I endoleak	13.0% 13/100 • Number of events 13
Surgical and medical procedures type II endoleak	7.0% 7/100 • Number of events 7
Surgical and medical procedures access failure	1.0% 1/100 • Number of events 1
Renal and urinary disorders urinary tract infection	4.0% 4/100 • Number of events 4
Gastrointestinal disorders bowel ischemia	3.0% 3/100 • Number of events 3
Vascular disorders thrombosis	3.0% 3/100 • Number of events 3
Skin and subcutaneous tissue disorders lymphocele	4.0% 4/100 • Number of events 4
Cardiac disorders angina	6.0% 6/100 • Number of events 6

Other adverse events

Measure	Treatment Arm - Placement of TAG Device n=100 participants at risk A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta
Vascular disorders aortic diameter enlargement	16.0% 16/100 • Number of events 16

Additional Information

Dr. Daniel Sze, Principal Investigator

Stanford University

Phone: 650-723-0728

Email: dansze@stanford.edu

Results disclosure agreements

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