Nectero EAST System Clinical Study

NCT06001918 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EAST002
• Study Type: interventional
• Target: 400
• Locations: 3 countries
• Sites: 39

Brief Summary

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

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The primary endpoint is the composite of all AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm).

  24 months

Secondary Outcomes (1)

• Growth

  24 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Drug: Nectero EAST System

Control Arm

NO 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.

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.

Treatment Arm

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
• 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.
• Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
• Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
• Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.
• Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.
• Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
• Subject has \> three-year life expectancy.
• 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.

You may not qualify if:

• Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
• Subject has a symptomatic infrarenal abdominal aortic aneurysm.
• Subject has a mycotic or infected aneurysm.
• Subject has current vascular injury due to trauma.
• Subject's aneurysm is thoracic, suprarenal or juxtarenal.
• Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
• 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.
• 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.
• 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.
• 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.
• Subject has undergone other major surgery within the 30 days prior to enrollment.
• Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months.
• Known allergy to contrast material that cannot be adequately premedicated, delivery system materials (i.e., nylon, polyurethane) and/or pentagalloylglucose (PGG).
• Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
• Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.).

Sponsors & Collaborators

• Nectero Medical, Inc.: lead

Study Sites (39)

Honor Health Scottsdale Shea Medical Center

Scottsdale, Arizona, 85258, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

ACTIVE NOT RECRUITING

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Prime Vascular Institute

Delray Beach, Florida, 33446, United States

ACTIVE NOT RECRUITING

Medical College of Georgia

Augusta, Georgia, 30912, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MaineMed Vascular Surgery

Scarborough, Maine, 04074, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

ACTIVE NOT RECRUITING

University of Massachusetts

Worcester, Massachusetts, 01655, United States

ACTIVE NOT RECRUITING

Beaumont Health

Royal Oak, Michigan, 48073, United States

ACTIVE NOT RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

ACTIVE NOT RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Stony Brook Medicine

Stony Brook, New York, 11794, United States

NOT YET RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

ACTIVE NOT RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

ACTIVE NOT RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Ohio Health Riverside

Columbus, Ohio, 43214, United States

RECRUITING

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

RECRUITING

Portland VA Medical Center

Portland, Oregon, 97239, United States

RECRUITING

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Jefferson Clinical Research Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

Prisma Health

Greenville, South Carolina, 29605, United States

RECRUITING

North Central Heart - A Division of Avera Heart Hospital

Sioux Falls, South Dakota, 57108, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Houston Healthcare

Houston, Texas, 77004, United States

RECRUITING

Baylor Scott & White Medical Center

Plano, Texas, 75093, United States

RECRUITING

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

RECRUITING

Inova Fairfax Medical Campus Inova Health Systems

Fairfax, Virginia, 22031, United States

RECRUITING

University of Washington at Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Bellin Memorial Hospital

Green Bay, Wisconsin, 54301, United States

RECRUITING

Prince of Wales Private Hospital- POW Vascular Institute

Randwick, New South Wales, 2031, Australia

RECRUITING

Auckland City Hospital

Auckland, 1023, New Zealand

RECRUITING

Related Publications (1)

• 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.

  PMID: 37330148 BACKGROUND

Related Links

• J Vasc Surg. Pilot Study

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Daniel Clair, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Grace Wang, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlene Knape

CONTACT

866-755-4744; cknape@necteromedical.com

Tracy Roberts

CONTACT

(303)3964603; troberts@necteromedical.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For this trial, neither the patient nor investigator will be blinded to the study group assignment. However, members of the Sponsor, the CT core laboratory and the various committees reviewing subject data, such as the Clinical Events Committee (CEC), will be blinded to the randomization and assignment arm for an individual subject under review.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled trial comparing the efficacy of the treatment arm to the control arm.

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 21, 2023
• Study Start: October 25, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

AU (1); US (37); NZ (1)