Clinical trial NCT01902888: Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm
Official title: Retrospective Evaluation of the GORE® VIABAHN® Endoprosthesis for a Popliteal Artery Aneurysm Indication
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Popliteal Artery Aneurysm
Keywords: popliteal artery
aneurysm
popliteal artery aneurysm
asymptomatic aneurysm
mural thrombus
Viabahn
Gore
Endoprosthesis
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2013-07-18
Enrollment: 3
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 who had popliteam aneurysm and were treated with GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.
timeFrame: 12 months following initial study procedure
measure: 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.
timeFrame: 30 days following initial study procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Health
state: Florida
city: Naples
country: United States
facility: The Vascular Group of Naples
state: Florida
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: W. L. Gore & Associates, Inc (sponsor)
name: Hector Novoa, BS
role: STUDY_DIRECTOR
References: