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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06001918




Registration number
NCT06001918
Ethics application status
Date submitted
7/08/2023
Date registered
21/08/2023
Date last updated
20/02/2025

Titles & IDs
Public title
Nectero EAST System Clinical Study
Scientific title
Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy.
Secondary ID [1] 0 0
EAST002
Universal Trial Number (UTN)
Trial acronym
stAAAble
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nectero EAST System

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

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.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Endpoint
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Growth
Timepoint [1] 0 0
24 months

Eligibility
Key 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).
Minimum age
21 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Private Hospital- POW Vascular Institute - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
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Arizona
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California
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Illinois
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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New Zealand
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Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nectero Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06001918
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Clair, MD
Address 0 0
Vanderbilt University Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Charlene Knape
Address 0 0
Country 0 0
Phone 0 0
866-755-4744
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06001918