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The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability | Device | Implant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Device Efficacy Events | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark F Fillinger, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Original EXCLUDER | Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure | Posted | Number | participants | 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endoleak | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tab Bonny | W.L. Gore and Associates | 928 864 4275 | tbonny@wlgore.com |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Lost to Follow-up |
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| Physician Decision |
|
| BG001 |
| Original EXCLUDER |
Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
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| Secondary | Number of Subjects With Device Efficacy Events | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 0 |
| 139 |
| 85 |
| 139 |
| EG001 | Original EXCLUDER | Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms. | 0 | 120 | 56 | 120 |
| Increase in Aneurysm Diameter | Vascular disorders |
|
| Other | Social circumstances |
|
| Unplanned Branch Vessel Occlusion | Surgical and medical procedures |
|
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| D001018 |
| Aortic Diseases |