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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Nectero EAST System
DrugTreated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Treatment ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Primary Endpoint
The primary endpoint is the composite of all AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm).
Time frame
24 monthsSecondary outcomes
1
Growth
The growth over time in aneurysm diameter based on CT core laboratory readings.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov