Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
400 participants
INTERVENTIONAL
2023-10-25
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Arm
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
Nectero EAST System
Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.
Control Arm
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nectero EAST System
Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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.
3. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
4. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
5. Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.
6. Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.
7. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
8. Subject has \> three-year life expectancy.
9. Subject is able and willing to comply with all required follow-up clinic visits including CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5 years) and blood draws.
Exclusion Criteria
2. Subject has a symptomatic infrarenal abdominal aortic aneurysm.
3. Subject has a mycotic or infected aneurysm.
4. Subject has current vascular injury due to trauma.
5. Subject's aneurysm is thoracic, suprarenal or juxtarenal.
6. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
7. Subject has anatomy of diffuse, ulcerated, or extensive (shaggy) thrombus in the neck of the AAA, that in the opinion of the vascular surgeon/investigator, could result in embolization of the thrombus.
8. Subject has anatomy of calcification, and/or plaque within the ilio-femoral arteries or severe infrarenal neck angulation that may compromise or does not allow delivery of the Introducer Sheath or the delivery catheter of the Nectero EAST System.
9. Subject has had a myocardial infarction within six (6) months prior to enrollment or elevated CK enzymes or troponin indicative of an evolving MI prior to procedure.
10. Subject has current angina, unstable angina, or other active cardiac condition such as congestive heart failure III and IV, atrial arrhythmia, ventricular arrhythmia, or valvular disease, requiring intervention.
11. Subject has undergone other major surgery within the 30 days prior to enrollment.
12. Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months.
13. Known allergy to contrast material that cannot be adequately premedicated, delivery system materials (i.e., nylon, polyurethane) and/or pentagalloylglucose (PGG).
14. Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
15. Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.).
16. Known contraindication to undergoing angiography or receiving systemic anticoagulation during the procedure.
17. Subject has active systemic infection.
18. Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial).
19. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from participation in the trial and to undergo the procedures and evaluations pre- and post-treatment.
20. Subject has dialysis dependent renal failure or baseline serum creatinine level \>2.5mg/dL or eGFR \< 45 mL/min/1.73m2.
21. Subjects with aminotransferase (ALT and/or AST) which is ≥1.5x upper limit of normal (ULN) or TB that is our of normal range for the evaluating laboratory.
22. Subjects that may not tolerate the lowering of their systolic blood pressure to approximately 100mmHg, should not be considered for this study or treated using the Nectero EAST System.
23. Subjects that may not be able to tolerate transient occlusion of the aorta should not be considered for this study.
24. Subjects with saccular AAA.
25. Subjects with rapidly expanding AAA (previous diameter increases of ≥0.5 cm in 6-months or ≥1 cm in 1 year) as these should be evaluated for immediate repair.
26. Subjects who are not suitable for the Nectero EAST System treatment, as determined by the investigator.
27. Subjects with INR out of normal range for the evaluating laboratory for a subject not on anti-coagulant therapy; or INR \>3 for a subject on anti-coagulant therapy.
28. Subjects with active/acute or a history of unstable chronic liver disease or current liver disease including but not limited to liver transplant, known genetic disorders such as Gilbert syndrome or other liver diseases.
29. Subjects with cirrhosis (e.g., known history or new clinical diagnosis by elastography with a fibrosis score of F3 or F4 and/or steatosis grade of S3).
30. Subjects with uncontrolled alcohol use disorder or current alcohol use putting them at risk of liver disease: including consumption of above one standard drink per day for women and two standard drinks per day for men.
31. Subjects with known right-sided heart failure or pathologically dilated inferior vena cava or hepatic veins indicative of congestive hepatopathy.
21 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nectero Medical, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Clair, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Grace Wang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Honor Health Scottsdale Shea Medical Center
Scottsdale, Arizona, United States
University of Colorado
Aurora, Colorado, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Prime Vascular Institute
Delray Beach, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
MaineMed Vascular Surgery
Scarborough, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
Beaumont Health
Royal Oak, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of Rochester
Rochester, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Ohio Health Riverside
Columbus, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Portland VA Medical Center
Portland, Oregon, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Jefferson Clinical Research Institute
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
North Central Heart - A Division of Avera Heart Hospital
Sioux Falls, South Dakota, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Houston Healthcare
Houston, Texas, United States
Baylor Scott & White Medical Center
Plano, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Inova Fairfax Medical Campus Inova Health Systems
Fairfax, Virginia, United States
University of Washington at Harborview Medical Center
Seattle, Washington, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, United States
Prince of Wales Private Hospital- POW Vascular Institute
Randwick, New South Wales, Australia
Auckland City Hospital
Auckland, , New Zealand
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Cheng SWK, Eagleton M, Echeverri S, Munoz JG, Holden AH, Hill AA, Krievins D, Ramaiah V. A pilot study to evaluate a novel localized treatment to stabilize small- to medium-sized infrarenal abdominal aortic aneurysms. J Vasc Surg. 2023 Oct;78(4):929-935.e1. doi: 10.1016/j.jvs.2023.05.056. Epub 2023 Jun 15.
Related Links
Access external resources that provide additional context or updates about the study.
J Vasc Surg. Pilot Study
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EAST002
Identifier Type: -
Identifier Source: org_study_id