Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms

NCT00615069 | Completed Phase 2 Results

• 1 other identifier: AAA 03-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms

Conditions

Aortic Aneurysm, Abdominal

Outcome Measures

Primary Outcomes (1)

• Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year

  Treatment through 1 year post-procedure (365 days)

Secondary Outcomes (1)

• Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications

  Treatment through 1 year window post-procedure (through end of 1 year window, 546 days)

Study Arms (1)

31 mm GORE EXCLUDER® Test Subjects

EXPERIMENTAL

GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)

Device: 31 mm GORE EXCLUDER® AAA Endoprosthesis

Interventions

31 mm GORE EXCLUDER® AAA Endoprosthesis DEVICE

GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)

Also known as: GORE EXCLUDER® Bifurcated Endoprosthesis

31 mm GORE EXCLUDER® Test Subjects

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Infrarenal AAA \> or equal to 4.5 cm in diameter
• Proximal infrarenal aortic neck length \> or equal 15mm
• Anatomy meets 31mm EXCLUDER specification criteria
• Access vessel able to receive 20 Fr. introducer sheath
• Life expectancy \>2 years
• Surgical candidate
• ASA Class I, II, III, or IV
• NYHA Class I, II, III
• years of age or older
• Male or infertile female
• Ability to comply with protocol requirements including follow-up
• Signed Informed Consent Form

You may not qualify if:

• Mycotic or ruptured aneurysm
• Participating in another investigational device or drug study within 1 year
• Documented history of drug abuse within 6 months
• Coexisting thoracic aortic aneurysm (50% larger than proximal aorta)
• Myocardial infarction or cerebral vascular accident within 6 weeks
• Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function
• Renal insufficiency (Creatinine \> 2.5 mg/dL) without dialysis
• Iliac anatomy that would require occlusion of both internal iliac arteries
• "Planned" occlusion or reimplantation of significant mesenteric or renal arteries
• "Planned" concomitant surgical procedure or previous major surgery within 30 days
• Previous prosthesis placement in the same position of the aorta or iliac arteries
• Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome
• Proximal neck angulation \> 60 degrees
• Presence of significant thrombus at arterial implantation sites

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Jennifer Gorman
• Organization: W.L. Gore and Associates

jgorman@wlgore.com

928 864 3381

Study Officials

• Jon S Matsumura, M.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: February 14, 2008
• Study Start: May 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2014
• Last Updated: April 14, 2015
• Results First Posted: July 9, 2009

Record last verified: 2015-03

Locations

US (1)