N/A
N=19
34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT00706394 ↗Enrolled (actual)
19
Serious AEs
73.7%
Results posted
Oct 2021
Primary outcome: Primary: Number of Participants With Proximal Type I Endoleak at Each Timepoint — 1; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endologix Powerlink 34 mm stent graft cuff (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endologix
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Proximal Type I Endoleak at Each Timepoint |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Successful Delivery and Deployment of the Device |
19 | — |
| SECONDARY Number of Participants With Type III Endoleaks at Each Timepoint |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Stent Fracture at Each Timepoint |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Stent Graft Obstruction at Each Timepoint |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Migration at Each Timepoint |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Type II Endoleaks at Each Timepoint |
4; 2; 0; 2; 1; 1 | — |
| SECONDARY Number of Participants With Aneurysm Diameter Change at Each Timepoint |
3; 11; 0; 3; 9; 0 | — |
| SECONDARY Maximum Diameter Measurements |
56; 57; 56; 56; 52; 46 | — |
| SECONDARY Aneurysm Volume Measurements |
203; 213; 217; 213; 164; 163 | — |
Summary
Study of anatomical fixation with a 34mm proximal extension
Eligibility Criteria
Inclusion Criteria
- 18 years old or older
- Informed consent understood and signed
- Will comply with protocol follow-up requirements
- Candidate for conventional open surgical repair
- Aneurysm outer diameter is one or more of the following:
- greater than or equal to 4.0cm
- greater than or equal to 3.0cm (saccular aneurysm)
- greater than or equal to twice the normal aortic outer diameter
- rapidly growing (greater than or equal to 5mm over 6 months)
- Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm
- Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm
- Iliac artery internal diameter greater than or equal to 8 mm
Exclusion Criteria
- Life expectancy 1.7 mg/dl
- Renal transplant patient
- Proximal attachment site >60º angle to the aneurysm body
- Iliac arteries >90º angle
- 30% at implantation site
Data sourced from ClinicalTrials.gov (NCT00706394). 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.