Actively Recruiting
Nectero EAST System Retreatment Study
Led by Nectero Medical, Inc. · Updated on 2026-04-01
10
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nectero EAST System Retreatment Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received initial Nectero EAST System treatment under protocol CTP-001.
- Males and females aged 21 to 85 years; females must be of non-childbearing potential (menopause or sterilization).
- Understands the trial purpose, agrees to participate voluntarily, signs informed consent, and is willing to complete follow-up.
- Infrarenal atherosclerotic fusiform abdominal aortic aneurysm 5.3 cm or less in males and 4.8 cm or less in females.
- Infrarenal aortic neck 15 mm or longer and 29 mm or less in diameter.
- Overall AAA treatment length not exceeding 130 mm.
- Iliac and femoral artery access suitable for 14F or larger introducer sheaths and catheters.
- Meets American Society of Anesthesiology (ASA) grade 1 through 3.
- Has more than two-year life expectancy.
- Able and willing to comply with all follow-up clinic visits including CT scans and blood draws.
You will not qualify if you...
- Has acutely ruptured, leaking, dissecting, or emergent aneurysm.
- Has symptomatic infrarenal abdominal aortic aneurysm.
- Has a mycotic or infected aneurysm.
- Has current vascular injury due to trauma.
- Aneurysm is thoracic, suprarenal, or juxtarenal.
- Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
- Diffuse, ulcerated, or extensive thrombus in the neck of the AAA that may cause embolization.
- Calcification, plaque in ilio-femoral arteries, or severe infrarenal neck angulation preventing delivery of devices.
- Myocardial infarction within six months prior or elevated enzymes indicating evolving MI.
- Current angina, unstable angina, or active serious cardiac conditions requiring intervention.
- Major surgery within 30 days prior to enrollment.
- Transient ischemic attack or ischemic stroke within 3 months.
- Known allergy to contrast material, delivery system materials, or pentagalloylglucose.
- Morbid obesity or conditions severely limiting X-ray visualization of the aorta.
- Connective tissue or collagen disorders (e.g., Marfan syndrome, Ehlers-Danlos Syndrome).
- Contraindication to angiography or systemic anticoagulation.
- Active systemic infection.
- Participation in another interfering research trial.
- Medical, social, or psychological problems preventing study participation.
- Dialysis dependent renal failure or poor kidney function (creatinine >2.5mg/dL or eGFR <45).
- Elevated liver enzymes or abnormal total bilirubin.
- Unable to tolerate lowering systolic blood pressure to ~100 mmHg.
- Unable to tolerate transient aorta occlusion.
- Saccular or rapidly expanding AAA.
- Unsuitable anatomy for Nectero EAST System treatment.
- Abnormal INR levels.
- Active or history of unstable chronic liver disease.
- Cirrhosis or advanced liver fibrosis.
- Uncontrolled alcohol use disorder or risky alcohol consumption.
- Known right-sided heart failure or signs of congestive hepatopathy.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Prince of Wales Private Hospital- POW Vascular Institute
Randwick, New South Wales, Australia, 2031
Not Yet Recruiting
2
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
Research Team
C
Charlene Knape
CONTACT
T
Tracy Roberts
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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