AAA - Abdominal Aortic AneurysmNCT07505082
Nectero EAST System Retreatment Study
A study testing Nectero EAST System in people with AAA - Abdominal Aortic Aneurysm and Aorta Aneurysm, run by Nectero Medical, Inc. at 2 sites in 2 countries.
Trial summary
This is an exploratory pilot study to evaluate the safety and clinical utility of retreatment with an investigational combination product called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- AAA - Abdominal Aortic Aneurysm, Aorta Aneurysm, Dilation Aorta
- 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
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Mar 2026to Feb 2029
- Phase
- Interventional
- 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
- Received initial Nectero EAST System treatment under protocol CTP-001.
- 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 ≤5.3 cm (male) and ≤4.8 cm (female).
- Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
- Overall AAA treatment length (distal renal artery to distal inferior margin of the aneurysm) not to exceed 130 mm.
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- 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 > two-year life expectancy.
- Subject is able and willing to comply with all required follow-up clinic visits including CT scans (screening, 6, 12, 24 months) 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.
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- 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 is out 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
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site, 1 recruiting
- 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
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1023
Cynthia Corne, 64 307 4949 Ext. 21505, CorneC@adhb.govt.nz
Andrew Holden
About this study
Official title: A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of Retreatment With the Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms
This is an exploratory pilot study to evaluate the safety and clinical utility of retreatment with an investigational combination product called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
- Being tested
- Nectero EAST System
- Keywords
- Abdominal Aorta, Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nectero EAST SystemCombination product
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Use of the EAST System for the stabilization treatment of AAA. The device is delivered endovascularly and placed in the AAA sac to deliver the Stabilizer Infusion Solution. Receives: Combination Product: Nectero EAST System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: technical success
Technical success as defined by successful insertion of the catheter and delivery of the Stabilizer Solution dose.
Measured: Up to 30 days
Safety: adverse events post-treatment
Treatment-related adverse events up to 30 days after retreatment with the Nectero EAST System.
Measured: Up to 30 days
Efficacy: aneurysm growth over time
Aneurysmal growth rate post-treatment over time as compared to the immediate pretreatment annual growth rate. The growth rate over time in aneurysm diameter will be based on CT core laboratory readings at 12- and 24-months post-treatment.
Measured: At 12 and 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start3 Mar 2026
- Primary completionDec 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AAA - Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Population diagnosed with abdominal aortic aneurysm ≤5.3 cm in males and ≤4.8 cm in females that have had a previous treatment with the Nectero EAST System.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nectero Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505082
- Sponsor's protocol ID
- EAST-003
- Status last verified
- May 2026
- First submitted
- 23 Mar 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of Retreatment With the Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT07505082
- Acronym / sponsor ID
- EAST-003
- Keywords
- Abdominal Aorta, Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nectero Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory pilot study to evaluate the safety and clinical utility of retreatment with an investigational combination product called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Population diagnosed with abdominal aortic aneurysm ≤5.3 cm in males and ≤4.8 cm in females that have had a previous treatment with the Nectero EAST System.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Combination Product: Nectero EAST SystemUse of the EAST System for the stabilization treatment of AAA. The device is delivered endovascularly and placed in the AAA sac to deliver the Stabilizer Infusion Solution. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Received initial Nectero EAST System treatment under protocol CTP-001.
- 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 ≤5.3 cm (male) and ≤4.8 cm (female).
- Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nectero EAST SystemParticipants 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. | Combination product | Interventional |
Primary outcome
Efficacy: technical success
Time frame: Up to 30 days
Technical success as defined by successful insertion of the catheter and delivery of the Stabilizer Solution dose.
Safety: adverse events post-treatment
Time frame: Up to 30 days
Treatment-related adverse events up to 30 days after retreatment with the Nectero EAST System.
Efficacy: aneurysm growth over time
Time frame: At 12 and 24 months post-treatment
Aneurysmal growth rate post-treatment over time as compared to the immediate pretreatment annual growth rate. The growth rate over time in aneurysm diameter will be based on CT core laboratory readings at 12- and 24-months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 37330148Cheng 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.
- J Vasc Surg. Pilot StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nectero EAST System in people with AAA - Abdominal Aortic Aneurysm and Aorta Aneurysm, run by Nectero Medical, Inc. at 2 sites in 2 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 10 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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.
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@necterotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: technical success (time frame: Up to 30 days). The study lists 3 primary outcomes in all. 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 NCT07505082, 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 26 May 2026.