RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

Nectero EAST System Clinical Study

Sponsor: Nectero Medical, Inc. • ClinicalTrials.gov ID: NCT06001918

Registry updated: 2026-09-28

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Description

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.

Interventions

Nectero EAST System (Drug)
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

Inclusion Criteria: 1. Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization). 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: 1. Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm. 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.

Conditions

Abdominal Aortic Aneurysm

Locations

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
Ascension Alexian Brothers — Elk Grove, 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
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
VA Tennessee Valley Healthcare System — Nashville, Tennessee, 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
Sentara Health — Norfolk, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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