Nectero EAST System Retreatment Study (NCT07505082) | Clinical Trial Compass
RecruitingNot Applicable
Nectero EAST System Retreatment Study
Australia, New Zealand10 participantsStarted 2026-03
Plain-language summary
This is an exploratory pilot study to evaluate the safety and clinical utility of retreatment with an investigational combination product called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
Who can participate
Age range21 Years – 85 Years
SexALL
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Inclusion criteria
✓. Received initial Nectero EAST System treatment under protocol CTP-001.
✓. Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
✓. 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.
✓. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm ≤5.3 cm (male) and ≤4.8 cm (female).
✓. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
✓. Overall AAA treatment length (distal renal artery to distal inferior margin of the aneurysm) not to exceed 130 mm.
✓. Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.
✓. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
Exclusion criteria
✕. Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
✕. Subject has a symptomatic infrarenal abdominal aortic aneurysm.
✕. Subject has a mycotic or infected aneurysm.
✕. Subject has current vascular injury due to trauma.
✕. Subject's aneurysm is thoracic, suprarenal or juxtarenal.
✕. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
✕. 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.
✕. 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.