Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm

NCT01902888 | Terminated Results

• 1 other identifier: PAA 12-01
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 3

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).

Conditions

Popliteal Artery Aneurysm

Keywords

popliteal artery; aneurysm; popliteal artery aneurysm; asymptomatic aneurysm; mural thrombus; Viabahn; Gore; Endoprosthesis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Popliteal aneurysm

GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm

Device: GORE® VIABAHN® Endoprosthesis

Interventions

GORE® VIABAHN® Endoprosthesis DEVICE

Also known as: Viabahn

Popliteal aneurysm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Bilateral popliteal artery aneurysms with initial treatment on the same day
• Had previous surgery for the popliteal artery aneurysm in the study limb

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (3)

Baptist Health

Miami, Florida, United States

Location

The Vascular Group of Naples

Naples, Florida, United States

Location

Washington University School of Medicine

St Louis, Missouri, United States

Location

MeSH Terms

Conditions

Popliteal Artery Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Early termination of study. No subject analysis done

Results Point of Contact

• Title: Arthur Scott / Clinical Study Manager
• Organization: W.L. Gore and Associates, Inc.

artscott@wlgore.com

623.208.3365

Study Officials

• Hector Novoa, BS

  W. L. Gore & Associates, Inc (sponsor)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 18, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 19, 2015
• Results First Posted: June 19, 2015

Record last verified: 2015-06

Locations

US (3)