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Procedure

Treatment Arm for Abdominal Aortic Aneurysm (stAAAble Trial)

Phase 2 & 3

Recruiting

Led By Daniel Clair, MD

Research Sponsored by Nectero Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.

Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

stAAAble Trial Summary

This trial is testing a new treatment for patients with small to mid-sized abdominal aortic aneurysms. The goal is to see if the treatment can stabilize these aneurysms. The trial

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical risks associated with endovascular procedures such as bleeding, infection, or damage to blood vessels.

stAAAble Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have an abdominal aortic aneurysm measuring within the specified range.

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I am in good to moderate health according to anesthesia safety standards.

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My blood vessels can support large catheters for treatment.

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My aneurysm treatment area is less than 130 mm long.

stAAAble Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Endpoint

Secondary outcome measures

Growth

stAAAble Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 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 ArmActive Control1 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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nectero Medical, Inc.Lead Sponsor

1 Previous Clinical Trials

46 Total Patients Enrolled

Daniel Clair, MDPrincipal InvestigatorVanderbilt University Medical Center

4 Previous Clinical Trials

387 Total Patients Enrolled

Grace Wang, MDPrincipal InvestigatorUniversity of Pennsylvania

4 Previous Clinical Trials

241 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"Indeed, according to the information provided on clinicaltrials.gov, this trial is currently seeking eligible participants. The initial posting date for this study was October 25th, 2023, and it underwent its most recent update on January 3rd, 2024."

Answered by AI

At how many distinct sites is the management of this study taking place?

"Honor Health Scottsdale Shea Medical Center in Scottsdale, Medstar Washington Hospital Center in Washington, and Prisma Health in Greenville are among the 7 active recruitment sites for this trial. Additionally, there are 4 more locations where patients can enroll."

Answered by AI

What is the overall count of participants who are registering for this research?

"Indeed, the information provided on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible patients. The trial was initially posted on October 25th, 2023 and was most recently updated on January 3rd, 2024. Across seven distinct locations, a total of 400 patient participants are being sought for enrollment in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nectero EAST System Clinical Study

2023. "Nectero EAST System Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001918.

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