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Abdominal Aortic AneurysmPhase 2/3stAAAbleNCT06001918

Nectero EAST System Clinical Study

A Phase 2/3 study testing Nectero EAST System in people with Abdominal Aortic Aneurysm, run by Nectero Medical, Inc. at 42 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 85 years
Conditions the study is for
Abdominal Aortic Aneurysm
What is being tested?
Nectero EAST System
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
42 sitesin 3 countries
Study dates
25 Oct 2023to 31 Dec 2032
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 31Show fewer
  • 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.).
  • Known contraindication to undergoing angiography or receiving systemic anticoagulation during the procedure.
  • Subject has active systemic infection.
  • Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial).
  • 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.
  • Subject has dialysis dependent renal failure or baseline serum creatinine level >2.5mg/dL or eGFR < 45 mL/min/1.73m2.
  • 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.
  • 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.
  • Subjects that may not be able to tolerate transient occlusion of the aorta should not be considered for this study.
  • Subjects with saccular AAA.
  • 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.
  • Subjects who are not suitable for the Nectero EAST System treatment, as determined by the investigator.
  • 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.
  • 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.
  • 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).
  • 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.
  • Subjects with known right-sided heart failure or pathologically dilated inferior vena cava or hepatic veins indicative of congestive hepatopathy.

Trial locations and contacts

42 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Charlene Knape contact

866-755-4744

cknape@necteromedical.com

Tracy Roberts contact

(303)3964603

troberts@necteromedical.com

42 sites in 3 countries

United States40 sites, 39 recruiting

  • Medical College of Georgia

    Augusta, Georgia, 30912

    Candelario Laserna, 706-721-2199, calaserna@augusta.edu

    Natasha Flores, nflores@augusta.edu

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Active, not recruiting

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

    Jena Hagerty, 484-658-4982, Jena.Hagerty@sluhn.org

    Sharvil Sheth, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Bonnie Chen, BCHEN13@mgh.harvard.edu

    Nikolaos Zacharias, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Monica Goyal, 617-632-7534, mgoyal@bidmc.harvard.edu

    Fernando Moreno, fmoreno@bidmc.harvard.edu

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    MacKenton Johnson, 773-795-3639, mackenton@bsd.uchicago.edu

    Ross Milner, MD

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Jamie Elkins, Jamie.Elkins@thechristhospital.com

    Geoff Answini, MD

    Recruiting

  • University Hospitals Cleveland

    Cleveland, Ohio, 44106

    Amy Kluge, Amy.Kluge@UHhospitals.org

    Jae Cho, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Laurie Ann Moennich, MOENNIL@ccf.org

    Francis Caputo, MD

    Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Subh Das, 614-366-6596, subhashish.das@osumc.edu

    Kristine Orion, MD

    Recruiting

  • Ohio Health Riverside

    Columbus, Ohio, 43214

    Regan Moran, Regan.Moran@ohiohealth.com

    Joseph Campbell, MD

    Recruiting

  • Prime Vascular Institute

    Delray Beach, Florida, 33446

    Jordan Sprechman, 561-495-3145, Jordan.Sprechman@tenethealth.com

    Alexia Medick, Alexia.Medick@tenethealth.com

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Ellen Burkett, (919)681-1878, ellen.jones@duke.edu

    Chandler Long, MD

    Recruiting

  • Ascension Alexian Brothers

    Elk Grove, Illinois, 60007

    Jack Chamberlin, MD

    Not yet recruiting

  • Inova Fairfax Medical Campus Inova Health Systems

    Fairfax, Virginia, 22031

    Bhruga Shah, Bhruga.shah@inova.org

    Kendal Endicott, MD

    Recruiting

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

    Katie Guilliams, Katherine.Guilliams@emplifyhealth.org

    Jason Ricci, MD

    Recruiting

  • Prisma Health

    Greenville, South Carolina, 29605

    Nikita Kasinger, Nikita.Kasinger@PrismaHealth.org

    Maggie Salle, Margaret.Salle@PrismaHealth.org

    Recruiting

  • Houston Healthcare

    Houston, Texas, 77004

    Swathi Potla, swathi.potla@hcahealthcare.com

    Kristofer Charlton-Ouw, MD

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Pauline Sirrell, pauline.sirrell@hitchcock.org

    Rebecca Scully, MD

    Recruiting

  • VA Tennessee Valley Healthcare System

    Nashville, Tennessee, 37212

    Sohpia Miner, Sophia.Miner@va.gov

    John Curci, MD

    Not yet recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Jennifer Scott, jennifer.scott@vumc.org

    Celia Nunez, celia.m.nunez@vumc.org

    Recruiting

  • Sentara Health

    Norfolk, Virginia, 23507

    Angela Zahn, AXZAHN@sentara.com

    David Dexter, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Jarod Phillips, jarphillips@unmc.edu

    Jonathan Thompson, MD

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Carolina Reyes, 215-615-8036, carolina.reyes1@pennmedicine.upenn.edu

    Grace Wang, MD

    Recruiting

  • Jefferson Clinical Research Institute

    Philadelphia, Pennsylvania, 19107

    Jona Shperdheja, Jona.Shperdheja@jefferson.edu

    Michael Nooromid, MD

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15219

    Judith Brimmeier, brimmeierja@upmc.edu

    Raymond Eid, MD

    Recruiting

  • Baylor Scott & White Medical Center

    Plano, Texas, 75093

    Saba Arianpour, Saba.Arianpour@BSWHealth.org

    William Shutze, MD

    Recruiting

  • Portland VA Medical Center

    Portland, Oregon, 97239

    Rachel Nelson, Rachel.Nelson1@va.gov

    Matthew Koopmann, MD

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Mary Bourret, Mary_Bourret@URMC.Rochester.edu

    Doran Mix, MD

    Recruiting

  • Beaumont Health

    Royal Oak, Michigan, 48073

    Lisa Bliss, lisa.bliss@corewellhealth.org

    Graham Long, MD

    Recruiting

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

    Julie Hales, Julie.Hales@hsc.utah.edu

    Cali Johnson, MD

    Recruiting

  • MaineMed Vascular Surgery

    Scarborough, Maine, 04074

    Kathryn Ackermann, kathryn.ackermann@mainehealth.org

    Kristina Giles, MD

    Recruiting

  • Honor Health Scottsdale Shea Medical Center

    Scottsdale, Arizona, 85258

    HonorHealth Cardiovascular Research, 480-323-1046

    Hasan Aldailami, MD

    Recruiting

  • University of Washington at Harborview Medical Center

    Seattle, Washington, 98104

    Allison Larimore, alari@uw.edu

    Benjamin Starnes, MD

    Recruiting

  • North Central Heart - A Division of Avera Heart Hospital

    Sioux Falls, South Dakota, 57108

    Patty Eisenbraun, RN, 605-977-5336, peisenbraun@ncheart.com

    Michael Bacharach, MD

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Briana K Langrehr, BSN, briana.l@wustl.edu

    Luis Sanchez, MD

    Recruiting

  • Stony Brook Medicine

    Stony Brook, New York, 11794

    Daria Shavarina, Daria.Shavarina@stonybrookmedicine.edu

    Rabih Chaer, MD

    Not yet recruiting

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

    Tia Whitaker, Tia.Whitaker@hillcrest.com

    Julia Chen, MD

    Recruiting

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Kassaye Sesaba, MD, 202-877-7452, Kassaye.T.Sesaba@medstar.net

    Suman Singh, MD, (202) 877-8475, Suman.Singh@Medstar.net

    Recruiting

  • University of Massachusetts

    Worcester, Massachusetts, 01655

    Shauneen Valliere, shauneen.valliere@umassmed.edu

    Andres Schanzer, MD

    Recruiting

Other trials in United States

Australia1 site, 1 recruiting

  • Prince of Wales Private Hospital- POW Vascular Institute

    Randwick, New South Wales, 2031

    Jade Goh, 04 87 369 396, pow.vascular.institute@gmail.com

    Ramon Varcoe

    Recruiting

Other trials in Australia

New Zealand1 site, 1 recruiting

  • Auckland City Hospital

    Auckland, 1023

    Cynthia Corne, +64 9 307 4949 ext. 21505, CorneC@adhb.govt.nz

    Andrew Holden, A/Prof

    Recruiting

Other trials in New Zealand

About this study

Official title: Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy.

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.

Being tested
Nectero EAST System
Keywords
Abdominal Aortic Aneurysm
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nectero EAST SystemDrug

    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.

Study groups in NCT06001918
Study groupRoleWhat they receive
Treatment ArmExperimentalParticipants 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
Receives: Drug: Nectero EAST System
Control ArmNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 24 months

Secondary outcomes (1)

  1. Growth

    The growth over time in aneurysm diameter based on CT core laboratory readings.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start25 Oct 2023
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, controlled trial comparing the efficacy of the treatment arm to the control arm.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06001918
Sponsor's protocol ID
EAST002
Acronym
stAAAble
Status last verified
May 2026
First submitted
7 Aug 2023
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 37330148

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nectero EAST System in people with Abdominal Aortic Aneurysm, run by Nectero Medical, Inc. at 42 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Charlene Knape (866-755-4744, cknape@necteromedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06001918, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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