Nectero EAST System Clinical Study
ConditionAbdominal Aortic Aneurysm
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-85
SponsorNectero Medical, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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 from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Nectero EAST System
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov