Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. >=18 years of age.
2. A candidate for elective EVAR of an infrarenal aortic aneurysm >=5.5 cm in
diameter in men and >=5.0 cm in women.

Exclusion Criteria

1. An inability to provide informed consent.
2. Enrolled in another clinical study.
3. Aortoiliac aneurysm, or concomitant iliac artery ectasia or aneurysm (common
iliac artery diameter >24 mm) close to the bifurcation and/or that cannot be
adequately sealed.
4. Patent AAA sac feeding vessels (within the sac) >4 mm in diameter.
5. Volume of AAA sac to be filled after stent graft placement <20 mL or >135
mL, based on pre-procedure CTA (i.e., aortic flow volume exclusive of stent
graft volume).
6. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis,
Cook Zenith Flex AAA Endovascular Graft, or Medtronic Endurant II Stent Graft
to treat the AAA.
7. Planned use of the chosen stent graft outside its instructions for use (IFU).
8. Planned use of fenestrated or chimney stent grafts.
9. Study participants in which stent graft placement is abandoned for any
reason, and/or in which the investigator decides, during the course of the
stent graft placement, that the study procedure may not be appropriate.
10. Planned use of embolic devices other than the investigational product to
embolize the AAA sac.
11. Vascular disease and/or anatomy that preclude the safe access and
positioning of a catheter to deliver the investigational product into the AAA
sac.
12. Ruptured, leaking, or mycotic (infected) aneurysm.
13. Aneurysmal disease of the descending thoracic aorta.
14. Coagulopathy or uncontrolled bleeding disorder.
15. Long-term (>6 months prior to the procedure) use of direct oral
anticoagulant or any vitamin K antagonist anticoagulant use.
16. Serum creatinine level >2.5 mg/dL.
17. Cerebrovascular accident within 3 months prior to the procedure.
18. Myocardial infarction and/or major heart surgery within 3 months prior to
the procedure.
19. Atrial fibrillation that is not well rate controlled.
20. Unable or unwilling to comply with study follow-up requirements.
21. Life expectancy of <2 years post-procedure.
22. Known hypersensitivity or contraindication to platinum, iridium, or
polyurethane.
23. A condition that inhibits radiographic visualization during the
implantation procedure.
24. History of allergy to contrast medium that cannot be managed medically.
25. Uncontrolled co-morbid medical condition, including mental health issues,
that would adversely affect participation in the study.
26. Pregnant or a lactating female. For females of child-bearing potential,
based on a positive pregnancy test within 7 days prior to the procedure or
refusal to use a medically accepted method of birth control for the duration of
the study.
27. Member of a vulnerable population.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints are:<br /><br>• Incidence of related major adverse events (MAEs), from the day of procedure<br /><br>through 30 days post-procedure. Relatedness to the investigational<br /><br>product/procedure to be adjudicated by the independent safety monitor.<br /><br>• Rate of technical success, defined as filling of the residual flow lumen of<br /><br>the AAA sac with investigational products, based on pre-procedure CTA and<br /><br>intra-procedural contrast-angiography of the residual blood lumen<br /><br>(lumenogram*).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other endpoints include the rate of adverse events through 5 years, the rates<br /><br>of endoleaks and other EVAR-related complications, and changes in sac size<br /><br>(diameter and volume) through 5 years.</p><br>