Nectero EAST System for Abdominal Aortic Aneurysm

(stAAAble Trial)

Recruiting at 37 trial locations

Overseen By Tracy Roberts

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Nectero Medical, Inc.

Disqualifiers: Cardiac conditions, Recent surgery, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: Single-dose

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with small to mid-sized abdominal aortic aneurysms (AAA), which are bulges in the main abdominal blood vessel. The treatment, known as the Nectero EAST System, involves a one-time, direct delivery of a special solution to the aneurysm through a minimally invasive procedure. Participants will be compared to those receiving usual care, which involves regular monitoring. The trial seeks individuals with an AAA between 3.5 cm and 5.0 cm who can commit to follow-up visits. As a Phase 2, Phase 3 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking medical advancements.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have conditions like unstable angina, active cardiac issues, or are on systemic anticoagulation, you may not be eligible. It's best to discuss your specific medications with the trial investigator.

What prior data suggests that the Nectero EAST System is safe for treating abdominal aortic aneurysms?

Research shows that the Nectero EAST System is generally well-tolerated. In a study testing this treatment, the procedure succeeded 100% of the time, indicating it can be administered safely without immediate issues.

While detailed information about long-term safety is still being collected, the successful initial use is promising. As this study progresses, earlier tests have demonstrated the treatment's reasonable safety. These studies continue to ensure the treatment's benefits outweigh any long-term risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for AAA?

Unlike the standard treatments for abdominal aortic aneurysm, which often involve surgical repair, the Nectero EAST System offers a minimally invasive approach. This system delivers the Stabilizer Infusion Solution directly into the aneurysm through an endovascular procedure. Researchers are excited because this one-time local delivery could potentially stabilize the aneurysm and reduce the need for major surgery. Additionally, the direct infusion method may improve patient outcomes by specifically targeting the aneurysm site, offering a novel way to manage this condition.

What evidence suggests that the Nectero EAST System is effective for abdominal aortic aneurysm?

Research has shown that the Nectero EAST System, which participants in this trial may receive, might help stabilize small to mid-sized abdominal aortic aneurysms (AAA). These aneurysms are bulges in the wall of the aorta, the body's main artery. The system delivers a special treatment directly into the bulge to strengthen the artery wall and prevent further enlargement. Early studies suggest this method can effectively halt the growth of these bulges, potentially reducing the risk of serious complications like rupture. The treatment is minimally invasive, requiring no large incisions, which can ease recovery. While more information is needed, these early results offer hope for improved outcomes for patients with AAAs. ^{1 2 3 4 6}

Who Is on the Research Team?

Daniel Clair

Principal Investigator

Vanderbilt University Medical Center

Grace Wang, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 21 with small to mid-sized abdominal aortic aneurysms (AAA), measuring 3.5-5.0 cm in diameter, who are not of childbearing potential and have suitable anatomy for the treatment. Participants must understand the study, consent to join, and be able to attend follow-up visits including CT scans.

Inclusion Criteria

The part of my aorta just above my kidneys is the right size for the procedure.

I am 21 or older. If female, I cannot have children (due to menopause or sterilization).

You comprehend the trial's objective, consent to willingly partake in it, sign the informed agreement and are disposed to finish subsequent follow-up actions as mandated by the protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time local delivery of the Stabilizer Infusion Solution using the Nectero EAST System

Single-dose

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with CT scans at designated intervals

24 months

Visits at 30/60 days, 6, 12, 18, and 24 months

Long-term follow-up

Continued annual follow-up for up to 5 years to monitor aneurysm stabilization

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Nectero EAST System

Trial Overview The Nectero EAST System is being tested as a single-dose endovascular treatment for AAAs compared to standard surveillance care. The goal is to see if it can stabilize AAAs effectively. Patients will be monitored at intervals up to five years post-treatment.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

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

Group II: Control Arm Active Control 1 Intervention

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.

Nectero EAST System is already approved in United States for the following indications:

Approved in United States as Nectero EAST System for:

• None approved yet; currently under investigation for stabilization of small to mid-sized abdominal aortic aneurysms (AAA)

Who Is Running the Clinical Trial?

Nectero Medical, Inc.

Lead Sponsor

Trials

2

Recruited

450+

Published Research Related to This Trial

In a study of 99 matched pairs undergoing endovascular aneurysm repair (EVAR), patients who received prophylactic EndoAnchors showed a significantly higher rate of aneurysm sac regression (81.1%) compared to the control group (48.7%) over 2 years (P = .01).

EndoAnchors appear to help counteract the negative effects of wide aortic necks and neck thrombus on sac regression, suggesting they may improve outcomes in challenging anatomical conditions, although further long-term studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. Muhs, BE., Jordan, W., Ouriel, K., et al.[2022]

Endovascular repair of abdominal aortic aneurysms is associated with complications such as endoleak, which occurs in a significant number of patients, raising concerns about the long-term effectiveness of the treatment.

Despite the risks, endovascular repair may provide some protection against aneurysm rupture, but patients require lifelong imaging surveillance and potential further interventions to monitor their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular treatment of abdominal aortic aneurysm. Gorham, TJ., Taylor, J., Raptis, S.[2004]

In a study of 335 patients undergoing endovascular aneurysm sealing (EVAS) with the Nellix system, there was no perioperative mortality and a low rate of early complications, indicating the procedure is safe for high-risk patients.

At 1-year follow-up, the freedom from aneurysm-related reintervention was 94.7%, suggesting that EVAS with the Nellix device is effective in managing abdominal aortic aneurysms with acceptable long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of endovascular aneurysm sealing from the multicenter Italian Research on Nellix Endoprosthesis (IRENE) study. Gossetti, B., Martinelli, O., Ferri, M., et al.[2022]

The Treo endograft demonstrated 100% technical success and no perioperative mortality in a cohort of 37 patients treated for abdominal aortic aneurysms (AAAs) over a mean follow-up of 5.5 years, indicating its safety and effectiveness.

Long-term outcomes showed a low reintervention rate of 5.5% and significant aneurysm shrinkage (mean of 11.25 mm), confirming that the Treo endograft maintains optimal results even in patients with hostile aortic anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-Year Outcomes of Endovascular Aortic Repair With the TREO Abdominal Endograft. Marone, EM., Marazzi, G., Brioschi, C., et al.[2023]

The Aptus Endovascular AAA Repair System demonstrated strong safety and feasibility in a Phase I study with 21 patients, showing no device-related adverse events or integrity failures at 30 days post-implantation.

Early follow-up results at 6 months and 1 year indicate promising outcomes, with no endoleaks, migrations, or conversions, supporting the potential for further evaluation in a larger Phase II trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The phase I multicenter trial (STAPLE-1) of the Aptus endovascular repair system: results at 6 months and 1 year. Deaton, DH., Mehta, M., Kasirajan, K., et al.[2012]

The ALTO abdominal stent graft system was successfully used to treat six male patients with abdominal aortic aneurysms, including two with juxtarenal aneurysms, with all procedures being uneventful.

At one-month follow-up, imaging showed no complications such as endoleak or graft failure, indicating promising early outcomes for this new polymer-based device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Juxtarenal Aortic Aneurysm Repair Using the ALTO Abdominal Stent Graft System: The First Case Series. Efthymiou, FO., Tsimpoukis, AL., Papatsirou, MA., et al.[2023]

Endovascular aneurysm repair is now a preferred treatment for abdominal aortic aneurysms because it is less invasive and has lower peri-operative mortality rates compared to traditional open surgery.

The Terumo Aortic TREO stent-graft, approved by the FDA in 2020, shows excellent clinical outcomes based on trials in the US and other countries, indicating improvements in long-term results and reducing the need for reintervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The TREO abdominal aortic stent-graft system. Boitano, L., Eagleton, MJ.[2022]

In a study of 14 patients undergoing EVAR surgery with prophylactic endosuturing, there were no technical complications and a high clinical success rate of 92.9%, indicating the procedure's efficacy in high-risk cases.

The use of the Medtronic Heli-FX system showed a low complication rate and no persistent endoleaks during an average follow-up of 7 months, demonstrating its safety for treating infrarenal aneurysms with challenging anatomical features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoanchoring may be effective in the endovascular aortic repair of juxtarenal aneurysms Fontanini, DM., Borzsák, S., Vecsey-Nagy, M., et al.[2022]

In a study of 220 patients who underwent endovascular abdominal aortic aneurysm repair (EAR), 24% developed endoleaks during an average follow-up of 19 months, highlighting the need for ongoing surveillance after the procedure.

The risk of developing an endoleak decreases with the number of negative imaging studies, but new endoleaks can still occur up to 7 years post-surgery, indicating that screening frequency should not be reduced without careful consideration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoleak following endovascular abdominal aortic aneurysm repair: implications for duration of screening. Corriere, MA., Feurer, ID., Becker, SY., et al.[2022]

The Nellix EndoVascular Aneurysm Sealing (EVAS) System successfully treated type IIIb endoleaks in two elderly patients, demonstrating its potential as an effective intervention for this complication after endovascular aneurysm repair.

At a follow-up of up to 6 months, both patients showed no signs of endoleaks, stable aneurysm sizes, and patent endografts, indicating the safety and efficacy of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Type IIIb Endoleaks After EVAR Using the Nellix EndoVascular Aneurysm Sealing System. van den Ham, LH., Wiersema, AM., Kievit, JK., et al.[2016]

The Nellix aneurysm sealing system is designed to seal aneurysm sacs and prevent complications like migration or endoleak, but it can cause serious complications, as demonstrated in a case where the filling material ruptured and displaced into the aorta, leading to peripheral ischemia.

In this case, the complication occurred in a patient with challenging vascular conditions, highlighting the need for caution when using the device in patients with hostile access routes or during secondary interventions; fortunately, the patient fully recovered after surgical removal of the material.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aortic Foreign Body Caused by Rupture of Endobag after EVAS Using the Nellix Aneurysm Sealing System-A Case Report. Frese, JP., Passaloglou, IT., Micheel, A., et al.[2017]

In a study of 365 patients who underwent endovascular abdominal aortic aneurysm repair (EVAR) with the AneuRx device, only 5.5% experienced suboptimal outcomes related to proximal attachment failure, often linked to unfavorable aortic neck anatomy.

Of the 20 patients with suboptimal outcomes, 90% successfully underwent endovascular treatments without major complications, indicating that most cases of proximal attachment failure can be effectively managed with endovascular strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aortic neck attachment failure and the AneuRx graft: incidence, treatment options, and early results. Azizzadeh, A., Sanchez, LA., Rubin, BG., et al.[2017]

The report details three successful procedures using visceral 'chimney stenting' with an endovascular aneurysm sealing (chEVAS) device to treat type 1a endoleak in patients with previous aneurysm repairs, demonstrating the technique's efficacy.

Out of the three cases, two patients showed no residual endoleak at follow-up periods of 10 and 14 months, although there was one postoperative death, indicating a need for careful monitoring of patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Technique of "Chimney Nellix" for the Management of Type 1a Endoleak After EVAR. Joseph, SZ., Kwok, CHR., Hockley, JA., et al.[2018]

The Nellix device is designed to effectively seal abdominal aortic aneurysms, aiming to minimize complications like endoleaks and the need for additional surgeries.

A case study of a 74-year-old male patient demonstrated the first open conversion of a Nellix endograft due to a serious complication (aortoduodenal fistula), highlighting potential risks associated with this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The First Case of a Nellix Sac-Anchoring Endoprosthesis Removal for Aortoenteric Fistula. Ferrero, E., Psacharopulo, D., Ferri, M., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06001918?term=NCT06001918&rank=1

NCT06001918 | Nectero EAST System Clinical Study 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 ...

2. necteromedical.com necteromedical.com/nectero-medical-receives-fda-clearance-of-ind-application-to-initiate-phase-ii-iii-clinical-trial-of-nectero-east-system-for-treatment-of-small-to-mid-sized-abdominal-aortic-aneurysms/

to Mid-Sized Abdominal Aortic Aneurysms “We believe the Nectero EAST® System has the potential to address a significant unmet clinical need and improve outcomes in AAA patients who currently have no ...

3. necteromedical.com necteromedical.com/products/

Products – Nectero Medical The Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST ® ) system is a minimally invasive technology currently undergoing clinical trials.

4. necteromedical.com necteromedical.com/nectero-medical-announces-initiation-of-phase-ii-iii-clinical-trial-of-the-nectero-east-system-for-treatment-of-small-to-medium-sized-abdominal-aortic-aneurysms/

to Medium-Sized Abdominal Aortic Aneurysms The safety and efficacy of the Nectero EAST System in treating patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5 – 5.0cm, is ...

5. vanderbilt.trialstoday.org vanderbilt.trialstoday.org/trial/NCT06001918

Nectero EAST System Clinical Study 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 ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0741521423013137

to medium-sized infrarenal abdominal aortic aneurysms This first-in-humans study utilizing the Nectero EAST System for the localized delivery of PGG resulted in 100% procedural success. The 30-day primary safety ...