A pilot study to evaluate a novel localized treatment to stabilize small- to medium-sized infrarenal abdominal aortic aneurysms.
Stephen W K Cheng, Matthew Eagleton, Santiago Echeverri...
https://pubmed.ncbi.nlm.nih.gov/37330148Actively Recruiting
Phase Not Applicable
Age: 21Years - 85Years
All Genders
ID07505082
A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of Retreatment With the Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms
Led by Nectero Medical, Inc. · Updated on 2026-05-26
10
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and usefulness of retreating Abdominal Aortic Aneurysms (AAA) using an investigational combination product called the Nectero EAST System. This exploratory pilot study focuses on participants who have previously received initial treatment with this system. The study aims to assess technical success, adverse events within 30 days, and aneurysm growth over 12 and 24 months after retreatment. Participants undergo a one-time endovascular procedure where the Nectero EAST System delivers a Stabilizer Infusion Solution directly into the aneurysm sac. This device is placed inside the aneurysm through blood vessels, using a catheter and introducer sheath. The treatment period includes the initial procedure and follow-up visits extending up to 24 months. During the study, participants will have clinic visits that include CT scans and blood draws at screening, 6, 12, and 24 months. Researchers will monitor the technical success of the treatment, any adverse events, and changes in the aneurysm size over time. The study requires participants to commit to these follow-up visits and assessments to evaluate the long-term impact of the retreatment with the Nectero EAST System.
CONDITIONS
Brief Title
Nectero EAST System Retreatment Study
Who Can Participate
Age: 21Years - 85Years
All Genders
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 willing to complete follow-up visits.
- Infrarenal atherosclerotic fusiform abdominal aortic aneurysm measuring 5.3 cm or less for males and 4.8 cm or less for females.
- Infrarenal aortic neck length of at least 15 mm and diameter no greater than 29 mm.
- Overall AAA treatment length not exceeding 130 mm.
- Iliac and femoral artery access allowing endovascular access with 14F or larger introducer sheaths and catheters.
- Meets American Society of Anesthesiology grade 1 through 3 criteria.
- Has a life expectancy of more than two years.
- Able and willing to comply with all required follow-up clinic visits including CT scans and blood draws.
You will not qualify if you...
- Has an acutely ruptured, leaking, dissecting, or emergent aneurysm.
- Has a 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 repair for abdominal aortic aneurysm.
- Diffuse, ulcerated, or extensive thrombus in the neck of the AAA likely to cause embolization.
- Calcification, plaque in ilio-femoral arteries, or severe infrarenal neck angulation preventing device delivery.
- Myocardial infarction within six months or elevated cardiac enzymes before procedure.
- Current angina, unstable angina, or other active serious cardiac conditions requiring intervention.
- Major surgery within 30 days prior to enrollment.
- Transient ischemic attack or ischemic stroke within 3 months.
- Allergy to contrast material, delivery system materials, or pentagalloylglucose that cannot be premedicated.
- Morbid obesity or other conditions severely limiting X-ray visualization of the aorta.
- Connective tissue or collagen disorders such as Marfan syndrome or vascular Ehlers-Danlos Syndrome.
- Contraindications to angiography or systemic anticoagulation.
- Active systemic infection.
- Participation in another research trial that could interfere.
- Other medical, social, or psychological issues preventing participation.
- Dialysis-dependent renal failure or poor kidney function.
- Elevated liver enzymes or abnormal liver function.
- Cannot tolerate lowering systolic blood pressure to about 100mmHg or transient aorta occlusion.
- Saccular or rapidly expanding AAA needing immediate repair.
- Not suitable for the Nectero EAST System treatment as determined by the investigator.
- Abnormal blood clotting parameters.
- Active or history of unstable chronic liver disease or cirrhosis.
- Uncontrolled alcohol use disorder or risk of liver disease.
- Known right-sided heart failure or signs of congestive hepatopathy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 30 days
Participants undergo a one-time endovascular procedure using the Nectero EAST System to stabilize their abdominal aortic aneurysm by delivering the Stabilizer Infusion Solution directly inside the aneurysm.
1 treatment visit (in-person)
Follow-up
Duration - Up to 24 months post-treatment
Participants are monitored for safety and effectiveness of the treatment, including assessments of aneurysm growth over time.
Visits at 12 and 24 months post-treatment
Trial Site Locations
Total: 2 locations
1
Prince of Wales Private Hospital- POW Vascular Institute
Randwick, New South Wales, Australia, 2031
Actively Recruiting
2
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
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Research Team
C
Charlene Knape
T
Tracy Roberts
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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