The ultimate purpose is to explore potential techniques to exclude aneurysms and provide
alternative conduit for arterial flow. The single center sponsorship is intended to provide
the investigators the potential to incorporate improvements in existing technology during
the course of the study thereby ultimately enhancing the potential for superior medical care
of patients suffering from these disease states.
The primary objective of this study is to examine the feasibility of expanded applications
of the basic Endologix technology for the treatment of arterial aneurysmal disease. A second
objective of this study is to gather data in order to make logical, scientific
recommendations for device design, construction and application which will expand the
application of the endoluminal graft technology and improve its safety and efficacy while
expanding the several potential future positive aspects of a less invasive method of
treating arterial occlusive disease.
Endologix, Inc. has applied for and received an IDE for the investigation of a bifurcated
device to exclude aneurysms of the abdominal aorta. The Arizona Heart Institute experience
indicates that this small study design will prove successful. Using the basic technology of
the current approved IDE, it is Arizona Heart Institute's intention to expand the scope of
application and design in order to address a greater population basis suffering from
aneurysmal disease. In this regard, the basic Endologix device designs will be applied to
appropriate patients beyond the scope of the current bifurcated IDE. Patients meeting the
criteria for the Endologix IDE will be enrolled independently in that study and followed
precisely in order to comply with the study design. Patients with aneurysmal disease not
currently filling the criteria for a bifurcated abdominal aortic prosthetic but who could
potentially benefit from the technology to exclude aneurysmal disease will be considered
from this study.
The patient's participation in the Study will include enrollment, Investigational Device
procedure and follow-up period. Patient data will be collected for 1, 6, and 12 months and
beyond as indicated. Subject follow-up at 1 month will include; ABIs, a complete Physical
Examination, Duplex Ultrasound, and X-ray. Subject follow-up at 6 and 12 months will also
include ABIs, a complete Physical Examination, CT Scan-Contrast Enhanced (unless
contraindicated), CT Scan-No Contrast, and X-ray.
- ≥ 18 years old
- Informed consent understood and signed.
- Compliance with post-treatment follow-up requirements.
- Candidates in this study may not be ideal surgical patients and therefore may be
included based upon the recommendation of the principal investigator or
co-investigators and one independent consultant confirming the opinion of the
- Patient may present as an emergency or urgent use patient with indications including:
ruptured aneurysm, dissected artery, or transected artery.
- Life expectancy < 2 years.
- Pregnant or lactating women.
- Indication that appropriate follow-up studies would for whatever reason be difficult
- Patient has other medical or psychiatric problems, which in the opinion of the
investigator, precludes them from participating in the study.
- Anticoagulation drugs are indicated.
- Coagulopathy or bleeding disorder.
- Active systemic or localized groin infection.
- Inferior mesenteric artery is indispensable.
- Creatinine level > 1.7 mg/dl.