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NCT06001918 · ClinicalTrials.gov registry record · Phase 2
Nectero EAST System Clinical Study
A Phase 2 study of Abdominal Aortic Aneurysm, sponsored by Nectero Medical.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06001918: Recruiting Phase 2 study of Abdominal Aortic Aneurysm, sponsored by Nectero Medical.
NCT06001918 is a Phase 2 study of Abdominal Aortic Aneurysm that is actively recruiting participants, run by Nectero Medical. The registered enrollment target is 400 participants, roughly in line with the 429-participant average among 16 other Abdominal Aortic Aneurysm trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06001918, a Phase 2 study of Abdominal Aortic Aneurysm, is actively recruiting participants, sponsored by Nectero Medical.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary endpoint is the composite of all AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm).
Conditions Studied
Interventions
- DRUG Nectero EAST System
Study Locations (20)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- University of Massachusetts - Worcester
Ohio
- The Christ Hospital - Cincinnati
- University Hospitals Cleveland - Cleveland
- Cleveland Clinic - Cleveland
New York
- University of Rochester - Rochester
- Stony Brook Medicine - Stony Brook
Arizona
- Honor Health Scottsdale Shea Medical Center - Scottsdale
Colorado
- University of Colorado - Aurora
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Florida
- Prime Vascular Institute - Delray Beach
Georgia
- Medical College of Georgia - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2023-10-25 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
What NCT06001918 shows while recruiting
NCT06001918 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 429-participant average among 16 other Abdominal Aortic Aneurysm trials with a reported enrollment target.
The record links to 1 condition, with Abdominal Aortic Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which Nectero EAST System is the first listed.
NCT06001918 names 20 study sites across 15 states, led by Massachusetts, Ohio, New York.
Frequently Asked Questions
What is clinical trial NCT06001918 about?
NCT06001918 is a clinical study titled "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 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of t...
What is the current status of trial NCT06001918?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2023-10-25. Estimated completion is 2029-12-31.
What conditions does trial NCT06001918 study?
This clinical trial studies the following conditions: Abdominal Aortic Aneurysm.
What interventions are being tested in trial NCT06001918?
The interventions under investigation include: Nectero EAST System (DRUG).
Who is sponsoring clinical trial NCT06001918?
This trial is sponsored by Nectero Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06001918 being conducted?
This trial has 20 study locations across Arizona, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06001918's enrollment target sits among peer trials
400 6th of 16 higher than 11 of 16 other Abdominal Aortic Aneurysm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Abdominal Aortic Aneurysm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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