Abdominal Aortic AneurysmAAANCT05133492
First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA)
A study testing Endovascular Aneurysm Stabilization Treatment (EAST) in people with Abdominal Aortic Aneurysm and AAA, run by Nectero Medical, Inc. at 5 sites in 5 countries.
Trial summary
This is a first in human study to evaluate the safety and clinical utility of an investigational medical device called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm, AAA, Dilation Aorta
- What is being tested?
- Endovascular Aneurysm Stabilization Treatment (EAST)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 24 Jun 2019to 31 Dec 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female aged 18 years or older
- Subject can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
- Infrarenal non-aneurysmal neck ≥15mm in length
- Aortic neck diameters ≤ 29mm
- Infrarenal neck angulation ≤ 60°
- Abdominal aneurysm from 3.5 cm to 5.0 cm.
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- Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 10 cm
- Patient iliac or femoral arteries access vessels' size and morphology allow endovascular access of 14F introducer sheaths and catheters.
- Subject has > one-year life expectancy.
- Subject is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive.
- Subject is able and willing to comply with 1, 3, 6, 12, 24 and 36-month follow-up.
Who cannot join
- Subject has an acutely ruptured or leaking or emergent aneurysm.
- Subject has a dissecting aneurysm.
- Subject has a mycotic or infected aneurysm.
- Subject has current vascular injury due to trauma.
- Subject's aneurysm is thoracic or suprarenal.
- Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
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- Subject has thrombus, calcification, and/or plaque that may compromise delivery.
- Subject has had a myocardial infarction within six (6) months prior to enrollment.
- Subject has current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia, or valvular disease.
- 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 polyester or contrast material that cannot be pretreated.
- Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
- Subject has connective tissue disease (e.g., Marfan syndrome, Eaton syndrome, or Bessel's disease).
- Known contraindication to undergoing angiography or anticoagulation.
- Subject has active systemic infection.
- Subject is participating in another research study.
- Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment.
- Women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the trial.
- Subject has dialysis dependent renal failure or baseline serum creatinine level >2.0mg/dl.
- Subjects with liver dysfunction: alanine transaminase (ALT) or aspartate transaminase (AST) is five times higher than the normal upper limit; serum total bilirubin (STB) is two times higher than the normal upper limit.
- Subjects who are not suitable for endovascular treatment, as judged by the investigator.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Australia1 site
Prince of Wales Private Hospital
Randwick, New South Wales, 2031
About this study
Official title: A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of The Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms
This is a first in human study to evaluate the safety and clinical utility of an investigational medical device called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
Read the detailed description
This is a Phase I multi-center, open-label study to evaluate use of the Nectero EAST system for stabilization of abdominal aortic aneurysms. Up to fifty (50) subjects will be treated at up to 10 worldwide sites with the device and followed for up to 36-months.
Primary Study Endpoints:
- Safety: absence of major events within the 1-month follow-up visit
- Success: defined as successful insertion of the delivery catheter and delivery of the Stabilizer
Secondary Study Endpoints:
- Freedom from aneurysmal sac enlargement. Enlargement is defined as diameter increase of >5mm per year, or aneurysm sac volume increase of >10% per year, as assessed by CT scans at the 1, 3, (HK only), 6, 12, 24 and 36-month follow-up visits.
- Aneurysm sac shrinkage, defined as diameter decrease of >5mm, or decrease in aneurysm sac volume of >10% as assessed by CT scans at the 1, 3 (HK only), 6, 12, 24 and 36-month follow-up visits.
- Assessment of Clinical Utility
Study duration is anticipated to be 6 years.
- Conditions
- Abdominal Aortic Aneurysm, AAA, Dilation Aorta
- Being tested
- Endovascular Aneurysm Stabilization Treatment (EAST)
- Keywords
- Abdominal Aorta, Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Aneurysm Stabilization Treatment (EAST)Device
Endovascular procedure: an ipsilateral ilio-femoral aortogram to confirm suitability for placement of a 14F sheath will be performed. A baseline contrast aortogram will be performed to assess vessel patency and target location of the EAST delivery catheter. Occluding and Stabilizer balloons are inflated in preparation for Stabilizer Compound delivery within the AAA sac. A post-Stabilizer angiogram will re-assess vessel patency and aorta stability. Delivery catheter is removed and discarded. The entire procedure is approximately one hour.
| 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: Device: Endovascular Aneurysm Stabilization Treatment (EAST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Procedure and Device-Related Adverse Events
Absence of major events (procedure and device-related) within the 1-month follow-up visit
Measured: Up to 30 days
Efficacy: Successful delivery of the EAST System into the AAA sac
Successful insertion of the delivery catheter and delivery of the Stabilizer Compound
Measured: Up to 30 days
Secondary outcomes (2)
Efficacy: Evaluation of the AAA sac diameter over the 36 month follow up period.
Freedom from aneurysmal sac enlargement. Enlargement is defined as diameter increase of >5mm per year, or aneurysm sac volume increase of >10% per year, as assessed by CT scans at the 1, 3, (HK only), 6, 12, 24 and 36-month follow-up visits.
Measured: Through study completion, an average of 3 years
Efficacy: Evaluation of the AAA sac shrinkage over the 36 month follow up period.
Aneurysm sac shrinkage, defined as diameter decrease of >5mm, or decrease in aneurysm sac volume of >10% as assessed by CT scans at the 1, 3 (HK only), 6, 12, 24 and 36-month follow-up visits.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start24 Jun 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 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 small to medium-sized (3.5-5.0cm) abdominal aortic aneurym.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nectero Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Cheng, MD, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133492
- Sponsor's protocol ID
- CTP001
- Acronym
- AAA
- Status last verified
- Dec 2025
- First submitted
- 3 Nov 2021
- Last updated
- 16 Dec 2025
- 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 16 Dec 2025. 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 The Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT05133492
- Acronym / sponsor ID
- AAA / CTP001
- Conditions
- Abdominal Aortic Aneurysm, AAA, Dilation Aorta
- Keywords
- Abdominal Aorta, Aneurysm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Nectero Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Nov 2021 (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 a first in human study to evaluate the safety and clinical utility of an investigational medical device called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
Detailed description
This is a Phase I multi-center, open-label study to evaluate use of the Nectero EAST system for stabilization of abdominal aortic aneurysms. Up to fifty (50) subjects will be treated at up to 10 worldwide sites with the device and followed for up to 36-months.
Primary Study Endpoints:
- Safety: absence of major events within the 1-month follow-up visit
- Success: defined as successful insertion of the delivery catheter and delivery of the Stabilizer
Secondary Study Endpoints:
- Freedom from aneurysmal sac enlargement. Enlargement is defined as diameter increase of >5mm per year, or aneurysm sac volume increase of >10% per year, as assessed by CT scans at the 1, 3, (HK only), 6, 12, 24 and 36-month follow-up visits.
- Aneurysm sac shrinkage, defined as diameter decrease of >5mm, or decrease in aneurysm sac volume of >10% as assessed by CT scans at the 1, 3 (HK only), 6, 12, 24 and 36-month follow-up visits.
- Assessment of Clinical Utility
Study duration is anticipated to be 6 years.
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 small to medium-sized (3.5-5.0cm) abdominal aortic aneurym.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Endovascular Aneurysm Stabilization Treatment (EAST)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or Female aged 18 years or older
- Subject can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
- Infrarenal non-aneurysmal neck ≥15mm in length
- Aortic neck diameters ≤ 29mm
- Infrarenal neck angulation ≤ 60°
Key exclusion criteria (22 listed)
- Subject has an acutely ruptured or leaking or emergent aneurysm.
- Subject has a dissecting aneurysm.
- Subject has a mycotic or infected aneurysm.
- Subject has current vascular injury due to trauma.
- Subject's aneurysm is thoracic or suprarenal.
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 |
|---|---|---|
| Endovascular Aneurysm Stabilization Treatment (EAST)Endovascular procedure: an ipsilateral ilio-femoral aortogram to confirm suitability for placement of a 14F sheath will be performed. A baseline contrast aortogram will be performed to assess vessel patency and target location of the EAST delivery catheter. Occluding and Stabilizer balloons are inflated in preparation for Stabilizer Compound delivery within the AAA sac. A post-Stabilizer angiogram will re-assess vessel patency and aorta stability. Delivery catheter is removed and discarded. The entire procedure is approximately one hour. | Device | Interventional |
Primary outcome
Safety: Procedure and Device-Related Adverse Events
Time frame: Up to 30 days
Absence of major events (procedure and device-related) within the 1-month follow-up visit
Efficacy: Successful delivery of the EAST System into the AAA sac
Time frame: Up to 30 days
Successful insertion of the delivery catheter and delivery of the Stabilizer Compound
2 secondary outcomes
Efficacy: Evaluation of the AAA sac diameter over the 36 month follow up period.
Time frame: Through study completion, an average of 3 years
Efficacy: Evaluation of the AAA sac shrinkage over the 36 month follow up period.
Time frame: Through study completion, an average of 3 years
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 16 Dec 2025.
- 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. 2023 Jun 15:S0741-5214(23)01313-7Link 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. This study is not recruiting at the moment.
Stephen Cheng, MD principal investigator
Queen Mary Hospital, Hong Kong
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Aneurysm Stabilization Treatment (EAST) in people with Abdominal Aortic Aneurysm and AAA, run by Nectero Medical, Inc. at 5 sites in 5 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 11 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, China, Colombia, Latvia, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Procedure and Device-Related Adverse Events (time frame: Up to 30 days). The study lists 2 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 NCT05133492, 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 16 Dec 2025.