Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm

Popliteal Artery Aneurysm Clinical Trial

— PAA 12-01  

Official title:

Retrospective Evaluation of the GORE® VIABAHN® Endoprosthesis for a Popliteal Artery Aneurysm Indication

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01902888
• Other study ID #: PAA 12-01
• Status: Terminated
• Phase: N/A
• First received: July 16, 2013
• Last updated: June 17, 2015
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Aneurysm
• Popliteal Artery Aneurysm

Intervention

Device:
• GORE® VIABAHN® Endoprosthesis

Locations

Country	Name	City	State
United States	Baptist Health	Miami	Florida
United States	The Vascular Group of Naples	Naples	Florida
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	12 months following initial study procedure	No
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.	30 days following initial study procedure	Yes