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

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

A Clinical Study Evaluating the Use of the GORE EXCLUDER® AAA Endoprosthesis - 31mm In the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615069
• Other study ID #: AAA 03-02
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: March 23, 2015
• Start date: May 2006
• Est. completion date: June 2014

Study information

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

Clinical Trial 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

Description:

The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER® AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. A secondary objective was to compare device performance of the original GORE EXCLUDER® AAA Endoprosthesis to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2014
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

• 21 years of age or older

• Male or infertile female

• Ability to comply with protocol requirements including follow-up

• Signed Informed Consent Form

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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

Locations

Country	Name	City	State
United States	St. Vincent Healthcare	Billings	Montana

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	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)	Yes
Secondary	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)	No