N/A
N=76
Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System
Abdominal Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT01491945 ↗Enrolled (actual)
76
Serious AEs
65.8%
Results posted
Oct 2021
Primary outcome: Primary: Safety- Number of Major Adverse Events at 30 Days — 2; 3; 2; 1 Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ventana Fenestrated Stent Graft System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endologix
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety- Number of Major Adverse Events at 30 Days |
2; 3; 2; 1; 5; 4 | — |
| PRIMARY Effectiveness |
0; 1; 18; 5; 0; 0 | — |
| SECONDARY Safety- Number of Major Adverse Events > 30 Days to 5 Years |
28; 2; 3; 0; 0; 10 | — |
| SECONDARY Renal Dysfunction |
9; 11; 22; 16; 11; 11 | — |
| SECONDARY Endoleaks |
0; 0; 11; 0; 0; 0 | — |
| SECONDARY Clinical Utility Outcomes |
132; 401 | — |
| SECONDARY Time in ICU |
3 | — |
| SECONDARY Time to Hospital Discharge |
4 | — |
| SECONDARY Device Patency |
0; 2; 3; 0; 2; 2 | — |
| SECONDARY Device Integrity |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Aneurysm Sac Morphology |
69; 7; 1; 4; 8; 8 | — |
| SECONDARY Aneurysm Sac Diameter |
58.4; 59.3; 57.6; 57.1; 56.7; 55.5 | — |
| SECONDARY Clinical Utility Outcomes |
132; 401 | — |
Summary
The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
Eligibility Criteria
Inclusion Criteria
- Male or female at least 18 years old;
- Informed consent understood and signed and patient agrees to all follow-up visits;
- Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than the normal aortic diameter
- Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System:
- Adequate iliac/femoral access compatible with the required delivery systems
- Non-aneurysmal infrarenal aortic neck 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 or myocardial infarction;
- Prior renal transplant;
- Length of either renal artery to be stented 70% stenosis);
- An essential accessory renal artery;
- Indispensable inferior mesenteric artery;
- 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 (female patient of childbearing potential only)
- Existing renal stent;
- Pre-planned need for concomitant procedure (e.g. surgical conduit for vascular access, hypogastric artery embolization/coil, renal artery angioplasty)
Data sourced from ClinicalTrials.gov (NCT01491945). 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.