N/A
Completed N=44
Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
Source: ClinicalTrials.gov NCT00739401 ↗Enrolled (actual)
44
Serious AEs
25.0%
Results posted
Dec 2021
Primary outcomePrimary: Number of Subjects With Proximal Type I Endoleak — 2 Participants
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.
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 | — |
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. Informational only — not medical advice.