Trial Outcomes & Findings for GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms (NCT NCT00593814)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

139 participants

Primary outcome timeframe

2 years

Results posted on

2018-01-08

Participant milestones
Measure	EXCLUDER Low Permeability Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.	Original EXCLUDER Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
Overall Study STARTED	139	120
Overall Study COMPLETED	115	120
Overall Study NOT COMPLETED	24	0

Reasons for withdrawal
Measure	EXCLUDER Low Permeability Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.	Original EXCLUDER Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
Overall Study Death	7	0
Overall Study Withdrawal by Subject	7	0
Overall Study Lost to Follow-up	7	0
Overall Study Physician Decision	3	0

GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms

Baseline characteristics by cohort
Measure	EXCLUDER Low Permeability n=139 Participants Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.	Original EXCLUDER n=120 Participants Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.	Total n=259 Participants Total of all reporting groups
Age, Continuous	73.9 years STANDARD_DEVIATION 7.5 • n=5 Participants	72.6 years STANDARD_DEVIATION 7.7 • n=7 Participants	73.3 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	14 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	112 Participants n=5 Participants	106 Participants n=7 Participants	218 Participants n=5 Participants
Region of Enrollment United States	139 participants n=5 Participants	120 participants n=7 Participants	259 participants n=5 Participants

Timeframe: 2 years

Outcome measures
Measure	EXCLUDER Low Permeability n=104 Participants Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.	Original EXCLUDER n=102 Participants Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure	9 participants	31 participants

Timeframe: 2 years

Outcome measures
Measure	EXCLUDER Low Permeability n=139 Participants Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.	Original EXCLUDER n=120 Participants Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
Number of Subjects With Device Efficacy Events	14 Participants	19 Participants

Serious events: 0 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 56 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	EXCLUDER Low Permeability n=139 participants at risk Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.	Original EXCLUDER n=120 participants at risk Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
Injury, poisoning and procedural complications Endoleak	57.6% 80/139	34.2% 41/120
Vascular disorders Increase in Aneurysm Diameter	1.4% 2/139	20.0% 24/120
Social circumstances Other	5.0% 7/139	0.00% 0/120
Surgical and medical procedures Unplanned Branch Vessel Occlusion	2.9% 4/139	5.0% 6/120

W.L. Gore and Associates

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