Phase 4 N=259 Treatment

GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms

Aortic Aneurysm, Abdominal

Bottom Line

View on ClinicalTrials.gov: NCT00593814 ↗

Enrolled (actual)

259

Serious AEs

0.0%

Results posted

Aug 2010

Primary outcome: Primary: Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure — 9; 31 participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: W.L.Gore & Associates
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure	9; 31	<0.001 sig
SECONDARY Number of Subjects With Device Efficacy Events	14; 19	—

Summary

The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.

Eligibility Criteria

Inclusion Criteria

Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter
Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use
Access vessel able to receive 18 French introducer sheath
Life expectancy > 2 years
Appropriate candidate for endovascular repair
Ability to comply with protocol requirements including follow-up
21 years of age or older, male or infertile female**

Exclusion Criteria

Mycotic or ruptured aneurysm
Participating in another investigational device or drug study within one year
Documented history of drug abuse within six months
Myocardial infarction or cerebral vascular accident within six weeks
Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
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 aorta or iliac arteries
Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00593814). 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.