Clinical trial NCT00615069: Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms
Official title: A Clinical Study Evaluating the Use of the GORE EXCLUDER® AAA Endoprosthesis - 31mm In the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aortic Aneurysm, Abdominal
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year
timeFrame: Treatment through 1 year post-procedure (365 days)
Secondary outcomes:
measure: Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications
timeFrame: Treatment through 1 year window post-procedure (through end of 1 year window, 546 days)
Other outcomes:
Locations:
city: Billings
country: United States
facility: St. Vincent Healthcare
state: Montana
Study officials:
affiliation: University of Wisconsin, Madison
name: Jon S Matsumura, M.D.
role: PRINCIPAL_INVESTIGATOR
References: