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Procedure
Nectero EAST System for Abdominal Aortic Aneurysm (stAAAble Trial)
San Francisco, CA
Phase 2 & 3
Waitlist Available
Led By Grace Wang, MD
Research Sponsored by Nectero Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment for patients with small to mid-sized abdominal aortic aneurysms. The goal is to see if the treatment can stabilize these aneurysms. The trial
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Who is the study for?
This trial is for adults over 21 with small to mid-sized abdominal aortic aneurysms (AAA), measuring 3.5-5.0 cm in diameter, who are not of childbearing potential and have suitable anatomy for the treatment. Participants must understand the study, consent to join, and be able to attend follow-up visits including CT scans.Check my eligibility
What is being tested?
The Nectero EAST System is being tested as a single-dose endovascular treatment for AAAs compared to standard surveillance care. The goal is to see if it can stabilize AAAs effectively. Patients will be monitored at intervals up to five years post-treatment.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with endovascular procedures such as bleeding, infection, or damage to blood vessels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
The part of my aorta just above my kidneys is the right size for the procedure.
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I have an abdominal aortic aneurysm measuring within the specified range.
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I am in good to moderate health according to anesthesia safety standards.
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My blood vessels can support large catheters for treatment.
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My aneurysm treatment area is less than 130 mm long.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Endpoint
Secondary study objectives
Growth
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment1 Intervention
Participants assigned to the treatment arm 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. Following treatment, surveillance of their AAA will be conducted using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.
Intervention: Drug: Stabilizer
Group II: Control ArmActive Control1 Intervention
Participants assigned to the control arm will undergo surveillance of their AAA using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.
Find a Location
Closest Location:San Francisco VA Medical Center· San Francisco, CA
Who is running the clinical trial?
Nectero Medical, Inc.Lead Sponsor
1 Previous Clinical Trials
46 Total Patients Enrolled
Grace Wang, MDPrincipal InvestigatorUniversity of Pennsylvania
4 Previous Clinical Trials
241 Total Patients Enrolled
Daniel Clair, MDPrincipal InvestigatorVanderbilt University Medical Center
5 Previous Clinical Trials
687 Total Patients Enrolled