Who is eligible for clinical trial NCT06001918?

Participants must meet protocol criteria for Abdominal Aortic Aneurysm. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06001918 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-21

Nectero EAST System Clinical Study (NCT06001918)

🟢 Recruiting Phase2 / Phase3 💊 Investigational Drug / Biologic Sponsor: Nectero Medical, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (32 items).

Location: Honor Health Scottsdale Shea Medical Center — Scottsdale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (39 Sites)

Honor Health Scottsdale Shea Medical Center — Scottsdale, Arizona
University of Colorado — Aurora, Colorado
Medstar Washington Hospital Center — Washington D.C., District of Columbia
Prime Vascular Institute — Delray Beach, Florida
Medical College of Georgia — Augusta, Georgia
University of Chicago — Chicago, Illinois
MaineMed Vascular Surgery — Scarborough, Maine
Massachusetts General Hospital — Boston, Massachusetts
Beth Israel Deaconess Medical Center — Boston, Massachusetts
University of Massachusetts — Worcester, Massachusetts
Beaumont Health — Royal Oak, Michigan
Washington University School of Medicine — St Louis, Missouri
University of Nebraska Medical Center — Omaha, Nebraska
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire
University of Rochester — Rochester, New York
Stony Brook Medicine — Stony Brook, New York
Duke University Medical Center — Durham, North Carolina
The Christ Hospital — Cincinnati, Ohio
University Hospitals Cleveland — Cleveland, Ohio
Cleveland Clinic — Cleveland, Ohio
The Ohio State University Wexner Medical Center — Columbus, Ohio
Ohio Health Riverside — Columbus, Ohio
Oklahoma Heart Institute — Tulsa, Oklahoma
Portland VA Medical Center — Portland, Oregon
St. Luke's University Health Network — Bethlehem, Pennsylvania

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗