Nectero EAST System Clinical Study (stAAAble)

April 9, 2024 updated by: Nectero Medical, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health Scottsdale Shea Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hasan Aldailami, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Principal Investigator:
          • Steven Abramowitz, MD
        • Contact:
        • Contact:
    • Florida
      • Delray Beach, Florida, United States, 33446
      • Gainesville, Florida, United States, 32610
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Vascular Institute Baptist Health
        • Contact:
        • Principal Investigator:
          • Libby Watch, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • University of Chicago
        • Contact:
        • Principal Investigator:
          • Ross Milner, MD
    • Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Luis Sanchez, MD
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Contact:
        • Principal Investigator:
          • Rebecca Scully, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Principal Investigator:
          • Chandler Long, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
        • Principal Investigator:
          • Kristine Orion, MD
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Greenville, South Carolina, United States, 29605
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Recruiting
        • North Central Heart - A Division of Avera Heart Hospital
        • Principal Investigator:
          • Michael Bacharach, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • John Curci, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Hospital
        • Contact:
        • Principal Investigator:
          • Cali Johnson, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Not yet recruiting
        • Inova Fairfax Medical Campus Inova Health Systems
        • Contact:
        • Principal Investigator:
          • Kendal Endicott, MD
    • Washington
      • Seattle, Washington, United States, 98104
        • Not yet recruiting
        • University of Washington at Harborview Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin Starnes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males and females ≥21 - ≤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).

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 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, delivery system materials (i.e., nylon, polyurethane) and/or Pentagalloyl Glucose (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.
  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 liver dysfunction: alanine transaminase (ALT) or aspartate transaminase (AST) which is 3 times higher than the normal upper limit; serum total bilirubin (STB) that is 1.5 times higher than the normal upper limit or has clinical evidence of jaundice.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth
Time Frame: 24 months
The growth over time in aneurysm diameter based on CT core laboratory readings.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nectero Medical, Inc.

Investigators

  • Principal Investigator: Daniel Clair, MD, Vanderbilt University Medical Center
  • Principal Investigator: Grace Wang, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAST002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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