Trial Outcomes & Findings for Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms (NCT NCT00615069)
NCT ID: NCT00615069
Last Updated: 2015-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Treatment through 1 year post-procedure (365 days)
Results posted on
2015-04-14
Participant Flow
Recruitment: May 2006 - Mar 2009 (Study Subjects and Continued Access)
Participant milestones
| Measure |
31 mm GORE EXCLUDER® Test Subjects
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment. Participant Flow results reflect the final (5 year) data.
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|---|---|
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Overall Study
STARTED
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35
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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16
|
Reasons for withdrawal
| Measure |
31 mm GORE EXCLUDER® Test Subjects
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment. Participant Flow results reflect the final (5 year) data.
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|---|---|
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Overall Study
Death
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10
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Overall Study
Physician Decision
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2
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Overall Study
Withdrawal by Subject
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4
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Baseline Characteristics
Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms
Baseline characteristics by cohort
| Measure |
31 mm GORE EXCLUDER® Test Subjects
n=35 Participants
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment.
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|---|---|
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Age, Continuous
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73.9 years
STANDARD_DEVIATION 7.8 • n=99 Participants
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Sex: Female, Male
Female
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2 Participants
n=99 Participants
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Sex: Female, Male
Male
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33 Participants
n=99 Participants
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Region of Enrollment
United States
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35 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Treatment through 1 year post-procedure (365 days)Outcome measures
| Measure |
31 mm GORE EXCLUDER® Test Subjects
n=35 Participants
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up.
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|---|---|
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Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year
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84.0 days
Standard Error 24.2
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SECONDARY outcome
Timeframe: Treatment through 1 year window post-procedure (through end of 1 year window, 546 days)Outcome measures
| Measure |
31 mm GORE EXCLUDER® Test Subjects
n=35 Participants
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up.
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|---|---|
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Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications
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4 Participants
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Adverse Events
31 mm GORE EXCLUDER® Test Subjects
Serious events: 24 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
31 mm GORE EXCLUDER® Test Subjects
n=35 participants at risk
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA).
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|---|---|
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Blood and lymphatic system disorders
Bleeding
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8.6%
3/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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Cardiac disorders
Cardiac
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20.0%
7/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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|
Gastrointestinal disorders
Bowel
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20.0%
7/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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General disorders
Endoleak
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5.7%
2/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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General disorders
Other
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20.0%
7/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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Infections and infestations
Sepsis
|
5.7%
2/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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Injury, poisoning and procedural complications
Wound
|
11.4%
4/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
11.4%
4/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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|
Nervous system disorders
Neurologic
|
20.0%
7/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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Renal and urinary disorders
Renal Function
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5.7%
2/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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Respiratory, thoracic and mediastinal disorders
Pulmonary
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17.1%
6/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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Vascular disorders
Lumen Obstruction
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2.9%
1/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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Vascular disorders
Vascular
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11.4%
4/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result 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
| Measure |
31 mm GORE EXCLUDER® Test Subjects
n=35 participants at risk
GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA).
|
|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
17.1%
6/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result 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
|
25.7%
9/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result 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
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17.1%
6/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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General disorders
Endoleak
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51.4%
18/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
|
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General disorders
Other
|
45.7%
16/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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General disorders
Other Device Complication
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5.7%
2/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result 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
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22.9%
8/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result 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
|
5.7%
2/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result 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
|
14.3%
5/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result 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
|
17.1%
6/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result 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
|
17.1%
6/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result 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
|
14.3%
5/35 • Adverse Event results reflect the final (through 5 year) data.
Note: only 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 had to result in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
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Additional Information
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 willpostpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating study sites.
- Publication restrictions are in place
Restriction type: OTHER