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Closed due to internal and external factors.
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This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).
The primary objective is to evaluate the safety and efficacy of the GORE® VIABAHN® Endoprosthesis for the treatment of subjects with Popliteal Artery Aneurysms. The study population includes subjects with an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, symptomatic aneurysm (no diameter requirement) of the popliteal artery, or presence of mural thrombus (no diameter requirement) of the popliteal artery treated with the GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010. Starting with most recently treated within the above date range, patients meeting Inclusion/Exclusion will be enrolled, until a minimum of 50 subjects with adequate follow up to determine primary endpoints through 12 months will be provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Popliteal aneurysm | GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® VIABAHN® Endoprosthesis | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency. | A composite of freedom from failure of technical success or loss of primary patency at 12 months | 12 months following initial study procedure |
| Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure. | 30 day serious adverse events related to the initial study procedure or the study device. | 30 days following initial study procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who had popliteam aneurysm and were treated with GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010.
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| Name | Affiliation | Role |
|---|---|---|
| Hector Novoa, BS | W. L. Gore & Associates, Inc (sponsor) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health | Miami | Florida | United States | |||
| The Vascular Group of Naples |
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| ID | Title | Description |
|---|---|---|
| FG000 | Popliteal Aneurysm | GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm GORE® VIABAHN® Endoprosthesis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Popliteal Aneurysm | GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm GORE® VIABAHN® Endoprosthesis |
| 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 | Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency. | A composite of freedom from failure of technical success or loss of primary patency at 12 months | Posted | 12 months following initial study procedure |
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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 | Popliteal Aneurysm | GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm GORE® VIABAHN® Endoprosthesis |
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Early termination of study. No subject analysis done
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur Scott / Clinical Study Manager | W.L. Gore and Associates, Inc. | 623.208.3365 | artscott@wlgore.com |
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| ID | Term |
|---|---|
| D000094622 | Popliteal Artery Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Naples |
| Florida |
| United States |
| Washington University School of Medicine | St Louis | Missouri | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure. | 30 day serious adverse events related to the initial study procedure or the study device. | Posted | 30 days following initial study procedure |
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| 0 |
| 0 |
| 0 |
| 0 |
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