Clinical trial NCT02462876: Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA)
Official title: Post-market Study: Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Popliteal Artery Aneurysm
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2015-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or presence of mural thrombus (\< 2 cm) in the popliteal artery treated since the date of reimbursement in France.

Brief summary: This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.


Eligibility criteria: Inclusion Criteria:

Inclusion to the study requires the patient:

1. Received a GORE® VIABAHN® Endoprosthesis to treat a popliteal artery aneurysm
2. Had a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or the presence of mural thrombus (\< 2 cm) in the popliteal artery;
3. Was 18 years of age or older at the time of the treatment;
4. Had an elective popliteal artery aneurysm procedure;
5. Has provided Informed Consent, personally or through lawful representation as determined by applicable local regulations and state law

Exclusion Criteria:

Prior to or at the time of implant the patient is / has:

1. Bilateral popliteal artery aneurysms with initial treatment on the same day;
2. Thrombotic occlusion of the popliteal artery or PAA;
3. Marfan syndrome or Ehlers-Danlos syndrome;
4. Unable to tolerate antiplatelet therapy;
5. Thrombophilia requiring long term anticoagulation;
6. Known allergies to the GORE® VIABAHN® Endoprosthesis components;
7. Enrolled in another investigational drug or medical device trial where participation may have affected the outcome or treatment of the subject in the popliteal artery aneurysm study with the GORE® VIABAHN® Endoprosthesis or had previous surgery for the popliteal artery aneurysm in the study limb.

Primary outcomes:
measure: Number of Subjects With Primary Patency at 12 Months
timeFrame: 12 months
measure: Number of Subjects With a Safety-related Event at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Probability of Primary Patency
timeFrame: 12, 24, and 36 months
measure: Number of Subject With a Safety-related Event at 24 and 36 Months
timeFrame: 24 and 36 months
measure: Length of Hospital Stay
timeFrame: During hospitalization, approximately 1-2 days
measure: Length of Procedure
timeFrame: During procedure, approximately 120 minutes
measure: Probability of Primary Assisted Patency
timeFrame: 12, 24, and 36 months
measure: Probability of Freedom From Limb Loss
timeFrame: 12, 24, and 36 months
measure: Probability of Freedom From Repeat Intervention
timeFrame: 12, 24, and 36 months
measure: Probability of Secondary Patency
timeFrame: 12, 24, and 36 months
measure: Number of Subjects With Technical Success
timeFrame: Post-procedure at day 30
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaire de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaire de Strasbourg
name: Nabil Chakfé
role: PRINCIPAL_INVESTIGATOR
References: