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
Qualifiers
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
Treatments tested in this trial
- Nectero EAST System
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
2Australia
Prince of Wales Private Hospital- POW Vascular Institute2031, RandwickNew South Wales, Australia
New Zealand
Auckland City Hospital1023, Auckland New Zealand
Sponsors and collaborators
Nectero Medical, Inc.
Lead sponsor
Source ClinicalTrials.gov