Actively Recruiting
Nectero EAST System Clinical Study
Led by Nectero Medical, Inc. · Updated on 2026-03-30
400
Participants Needed
39
Research Sites
322 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.
CONDITIONS
Official Title
Nectero EAST System Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 21 to 85 years; females must be of non-childbearing potential (menopause or sterilization)
- Understand and agree to participate voluntarily, sign informed consent, and commit to follow-up visits
- Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) or 3.5 cm to 4.5 cm (female)
- Infrarenal aortic neck at least 15 mm in length and no more than 29 mm in diameter
- Overall aneurysm treatment length not to exceed 130 mm
- Iliac and femoral artery access suitable for 14F or larger introducer sheaths and catheters
- American Society of Anesthesiology (ASA) grade 1 through 3
- Life expectancy greater than three years
- Willing and able to comply with all required follow-up visits, CT scans, and blood draws
You will not qualify if you...
- Acutely ruptured, leaking, dissecting, or emergent aneurysm
- Symptomatic infrarenal abdominal aortic aneurysm
- Mycotic or infected aneurysm
- Current vascular injury due to trauma
- Thoracic, suprarenal, or juxtarenal aneurysm
- Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm
- Diffuse, ulcerated, or extensive thrombus in aneurysm neck that could cause embolization
- Calcification, plaque in ilio-femoral arteries, or severe neck angulation preventing device delivery
- Myocardial infarction within 6 months prior to enrollment or signs of evolving MI
- Current angina, unstable angina, congestive heart failure class III or IV, or serious arrhythmias
- 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
- Morbid obesity or conditions severely limiting X-ray visualization of the aorta
- Connective tissue or collagen disorders such as Marfan syndrome or Ehlers-Danlos Syndrome
- Contraindications to angiography or systemic anticoagulation
- Active systemic infection
- Participation in other conflicting research trials
- Medical, social, or psychological problems preventing participation
- Dialysis-dependent renal failure or impaired kidney function
- Elevated liver enzymes or abnormal bilirubin levels
- Inability to tolerate blood pressure lowering or transient aortic occlusion
- Saccular or rapidly expanding aneurysm
- Unsuitability for Nectero EAST System treatment as determined by investigator
- Abnormal INR levels
- Active or history of unstable liver disease or cirrhosis
- Uncontrolled alcohol use 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
Trial Site Locations
Total: 39 locations
1
Honor Health Scottsdale Shea Medical Center
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
University of Colorado
Aurora, Colorado, United States, 80045
Active, Not Recruiting
3
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Prime Vascular Institute
Delray Beach, Florida, United States, 33446
Active, Not Recruiting
5
Medical College of Georgia
Augusta, Georgia, United States, 30912
Actively Recruiting
6
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
7
MaineMed Vascular Surgery
Scarborough, Maine, United States, 04074
Not Yet Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
10
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Active, Not Recruiting
11
Beaumont Health
Royal Oak, Michigan, United States, 48073
Active, Not Recruiting
12
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
13
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
14
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Active, Not Recruiting
15
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
16
Stony Brook Medicine
Stony Brook, New York, United States, 11794
Not Yet Recruiting
17
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
18
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
19
University Hospitals Cleveland
Cleveland, Ohio, United States, 44106
Active, Not Recruiting
20
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
21
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
22
Ohio Health Riverside
Columbus, Ohio, United States, 43214
Actively Recruiting
23
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
24
Portland VA Medical Center
Portland, Oregon, United States, 97239
Actively Recruiting
25
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Actively Recruiting
26
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
27
Jefferson Clinical Research Institute
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
28
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
29
Prisma Health
Greenville, South Carolina, United States, 29605
Actively Recruiting
30
North Central Heart - A Division of Avera Heart Hospital
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
31
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
32
Houston Healthcare
Houston, Texas, United States, 77004
Actively Recruiting
33
Baylor Scott & White Medical Center
Plano, Texas, United States, 75093
Actively Recruiting
34
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Actively Recruiting
35
Inova Fairfax Medical Campus Inova Health Systems
Fairfax, Virginia, United States, 22031
Actively Recruiting
36
University of Washington at Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
37
Bellin Memorial Hospital
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
38
Prince of Wales Private Hospital- POW Vascular Institute
Randwick, New South Wales, Australia, 2031
Actively Recruiting
39
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
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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