Popliteal Artery Aneurysm
Conditions
Keywords
popliteal artery, aneurysm, popliteal artery aneurysm, asymptomatic aneurysm, mural thrombus, Viabahn, Gore, Endoprosthesis
Brief summary
This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).
Detailed description
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.
Interventions
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Received a GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010 to treat a popliteal artery aneurysm; * Had an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or symptomatic aneurysm (no diameter requirement) of the popliteal artery, or the presence of mural thrombus (no diameter requirement) of the popliteal artery; * Was 18 years of age or older; and * Had an elective popliteal artery aneurysm procedure.
Exclusion criteria
* Bilateral popliteal artery aneurysms with initial treatment on the same day * Had previous surgery for the popliteal artery aneurysm in the study limb
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency. | 12 months following initial study procedure | A composite of freedom from failure of technical success or loss of primary patency at 12 months |
| 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 days following initial study procedure | 30 day serious adverse events related to the initial study procedure or the study device. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Popliteal Aneurysm GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
GORE® VIABAHN® Endoprosthesis | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Terminated | 3 |
Baseline characteristics
| Characteristic | Popliteal Aneurysm |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 12.28 |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: 12 months following initial study procedure
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.
Time frame: 30 days following initial study procedure