IRB Study Number 23-753
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The purpose of this study is to see if a three-dimensional (3D) visualization system can be used as an addition to standard 2D imaging to provide more accurate guidance to the aneurysm site and decrease procedure time, limiting x-ray exposure. You will be asked to allow both 2D and 3D imaging to be used during your EVAR procedure. Other activities such as data collection (i.e. medical and surgical history), physical exam and follow-up visit are part of the standard care for any patient that is having EVAR.
Inclusion Criteria
- Patient meets IFU criteria for the 24-28 mm body Cook Zenith Flex AAA stent graft.
- Male/female, aged ≥ 18 years of age.
- Patient fulfilling criteria for needing endovascular repair of abdominal aortic aneurysm according to routine clinical practice criteria of the participating center.
- Women of childbearing potential must be non-pregnant, non-lactating, and not planning to become pregnant during the course of the trial; and have a negative urine or serum pregnancy test within 7 days prior to index procedure.
- Provide written informed consent.
- Stated willingness to comply with all study procedure sand availability for the duration of the study.
Exclusion Criteria
- Patients with known sensitivities or allergies to stainless steel, polyester, solder (tin silver), polypropylene, or gold.
- Patients with a systemic infection who may be at increased risk of endovascular graft infection.
- Presence of electronic implants, e.g., cardiac pacemaker, AICD, or nerve stimulator.
- Presence of metallic implants above the knee, e.g., artificial hip.
- Pregnant women.
- Patients’ inability to have contrasted CT scan.
- Current or planned participation in any other investigational drug or medical device clinical study that has not completed primary endpoint(s) evaluation.
- Other medical, social, or psychological issues that in the opinion of the investigator preclude the subjects from receiving this treatment, and the procedures and evaluations pre and post treatment.
