RecruitingAbdominal Aortic Aneurysm

Nectero EAST System Clinical Study

Eligible age

21–85 yrs

Accepts

All genders

Locations

26 states

Healthy volunteers

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About this study

The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.

Sponsor: Nectero Medical, Inc.

You may qualify if…

✓ 1. Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
✓ 2. Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
✓ 3. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
✓ 4. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
✓ 5. Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.
✓ 6. Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.
✓ 7. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
✓ 8. Subject has \> three-year life expectancy.

You may not qualify if…

✕ 1. Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
✕ 2. Subject has a symptomatic infrarenal abdominal aortic aneurysm.
✕ 3. Subject has a mycotic or infected aneurysm.
✕ 4. Subject has current vascular injury due to trauma.
✕ 5. Subject's aneurysm is thoracic, suprarenal or juxtarenal.
✕ 6. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
✕ 7. Subject has anatomy of diffuse, ulcerated, or extensive (shaggy) thrombus in the neck of the AAA, that in the opinion of the vascular surgeon/investigator, could result in embolization of the thrombus.
✕ 8. Subject has anatomy of calcification, and/or plaque within the ilio-femoral arteries or severe infrarenal neck angulation that may compromise or does not allow delivery of the Introducer Sheath or the delivery catheter of the Nectero EAST System.