Trial Outcomes & Findings for Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms (NCT NCT00590759)

NCT ID: NCT00590759

Last Updated: 2014-08-07

Results Overview

Freedom from aneurysm related mortality for TAG 05-02 subjects

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2014-08-07

Participant Flow

Participant milestones

Measure	Thoracic Endograft GORE TAG® Thoracic Endoprosthesis: implant
Overall Study STARTED	150
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	80

Reasons for withdrawal

Measure	Thoracic Endograft GORE TAG® Thoracic Endoprosthesis: implant
Overall Study Death	52
Overall Study Lost to Follow-up	28

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Thoracic Endograft n=150 Participants GORE TAG® Thoracic Endoprosthesis: implant
Age, Continuous	72.1 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants
Region of Enrollment United States	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Freedom from aneurysm related mortality for TAG 05-02 subjects

Outcome measures

Measure	Thoracic Endograft n=150 Participants GORE TAG® Thoracic Endoprosthesis: implant
Aneurysm Related Death	4 participants

SECONDARY outcome

Timeframe: 5 years

Proportion of subjects in TAG 05-02 with MAEs

Outcome measures

Measure	Thoracic Endograft n=150 Participants GORE TAG® Thoracic Endoprosthesis: implant
A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.	22 participants

Adverse Events

0502 TAG Device Subjects

Serious events: 0 serious events

Other events: 147 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	0502 TAG Device Subjects n=150 participants at risk
Blood and lymphatic system disorders Bleeding Complication	34.7% 52/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Cardiac disorders Cardiac Complication	42.7% 64/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Gastrointestinal disorders Bowel Complication	36.0% 54/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
General disorders Additional Implantation	10.7% 16/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
General disorders Other Complication	68.0% 102/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Injury, poisoning and procedural complications Endoleak	38.7% 58/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Injury, poisoning and procedural complications Wound Complication	28.7% 43/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	10.0% 15/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Nervous system disorders Neurologic Complication	41.3% 62/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Renal and urinary disorders Genitourinary	26.7% 40/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Renal and urinary disorders Renal Function Complication	17.3% 26/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Respiratory, thoracic and mediastinal disorders Pulmonary Complication	44.7% 67/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Vascular disorders Vascular Complication	37.3% 56/150 • Total Study Follow-up. Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"

Additional Information

Robert Makowsky

W. L. Gore and Associates, Inc.

Phone: 6232345784

Email: rmakowsk@wlgore.com

Results disclosure agreements

• Principal investigator is a sponsor employee Gore has the right to review disclosures, requesting a delay of less than 90 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