Nectero EAST System Retreatment Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorNectero Medical, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
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
Single group
Treatments tested in this trial
Nectero EAST System
Combination productParticipants will undergo an endovascular procedure using the Nectero EAST System to deliver the Stabilizer Infusion Solution directly inside the aneurysm. This is a one-time local delivery of the product.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: InterventionalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy: technical success
Technical success as defined by successful insertion of the catheter and delivery of the Stabilizer Solution dose.
Time frame
Up to 30 days2
Safety: adverse events post-treatment
Treatment-related adverse events up to 30 days after retreatment with the Nectero EAST System.
Time frame
Up to 30 days3
Efficacy: aneurysm growth over time
Aneurysmal growth rate post-treatment over time as compared to the immediate pretreatment annual growth rate. The growth rate over time in aneurysm diameter will be based on CT core laboratory readings at 12- and 24-months post-treatment.
Time frame
At 12 and 24 months post-treatmentSponsors and contacts
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Source ClinicalTrials.gov