N/A
N=44
Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT00739401 ↗Enrolled (actual)
44
Serious AEs
25.0%
Results posted
Dec 2021
Primary outcome: Primary: Number of Subjects With Proximal Type I Endoleak — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Suprarenal Proximal Cuff Extension (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endologix
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Proximal Type I Endoleak |
2 | — |
| SECONDARY Number of Subjects With Major Adverse Events |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Stent Graft Integrity and Performance |
0; 0; 0; 0 | — |
| SECONDARY Endoleak |
2; 6; 1 | — |
| SECONDARY Aneurysm Morphology Changes |
170 | — |
| SECONDARY Renal Function |
1.08 | — |
| SECONDARY Aneurysm Morphology Changes |
170 | — |
Summary
The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.
Eligibility Criteria
Inclusion Criteria
- 18 years old
- Informed consent understood and signed
- Will comply with post-treatment follow-up requirements up to 5 years
- Candidate for Powerlink Infrarenal Bifurcated Graft
Exclusion Criteria
- Life expectancy 1.7mg/dl
- Renal transplant patient
- Patient with > 75% renal artery stenosis and not eligible for PTA/stent intervention prior to suprarenal device fixation
Data sourced from ClinicalTrials.gov (NCT00739401). 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.