Phase 2
N=35
Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms
Aortic Aneurysm, Abdominal
Bottom Line
View on ClinicalTrials.gov: NCT00615069 ↗Enrolled (actual)
35
Serious AEs
68.6%
Results posted
Jul 2009
Primary outcome: Primary: Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year — 84.0 days — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 31 mm GORE EXCLUDER® AAA Endoprosthesis (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year |
84.0 | 0.003 sig |
| SECONDARY Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications |
4 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT00615069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.