N/A
N=49
Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
Abdominal Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT01348828 ↗Enrolled (actual)
49
Serious AEs
85.7%
Results posted
Oct 2021
Primary outcome: Primary: Primary Safety Endpoint — 0; 0; 0; 1 events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endologix
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint |
0; 0; 0; 1; 7; 2 | — |
| SECONDARY Feasibility/Effectiveness |
31; 18; 47; 1; 1; 13 | — |
| SECONDARY Procedural/In-hospital Evaluations |
5 | — |
| SECONDARY Mortality |
20; 5 | — |
| SECONDARY Major Adverse Events |
6; 0; 2; 0; 0; 4 | — |
| SECONDARY Number of Participants With Renal Dysfunction |
4; 2; 2; 9; 5; 4 | — |
| SECONDARY Aneurysm Rupture |
0; 0; 1; 2; 0; 1 | — |
| SECONDARY Conversion to Open Repair |
0; 0; 0; 1; 1; 0 | — |
| SECONDARY Device Integrity |
0; 1; 0; 0; 1; 1 | — |
| SECONDARY Stent Graft Patency |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Aneurysm Diameter Change |
4; 1; 34; 38; 7; 0 | — |
| SECONDARY Secondary Procedures |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Procedural/In-hospital Evaluations |
5 | — |
| SECONDARY Procedural/In-hospital Evaluations |
5 | — |
Summary
The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
Eligibility Criteria
Inclusion Criteria
- Adequate iliac/femoral access compatible with the required delivery systems
- Non-aneurysmal infrarenal aortic neck = 70
- SMA to aortoiliac bifurcation length >=90mm
- Proximal non-aneurysmal aortic neck below the SMA with diameter 18 to 34 mm, length >=15mm and angle =15mm, with diameter >=10 mm and 2.0 mg/dL
- Traumatic vascular injury
- Active systemic or localized groin infection
- Connective tissue disease (e.g., Marfan's Syndrome)
- Recent(within prior three months)cerebrovascular accident
- Recent(within prior three months)myocardial infarction
- Prior renal transplant
- Length of either renal artery to be stented 70%)
- An essential accessory renal artery
- Indispensable inferior mesenteric artery
- Untreated aneurysmal disease of the descending thoracic aorta
- Clinically significant mural thrombus circumferentially in the suprarenal segment
- Prior iliac artery stent implanted that may interfere with delivery system introduction
- Unsuitable vascular anatomy
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01348828). 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.