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NCT03214601 · ClinicalTrials.gov registry record · NA
Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System
A NA study of Aortic Aneurysm and Aneurysm, Ruptured, sponsored by Bolton Medical.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 12
- Study locations
NCT03214601: Active NA study of Aortic Aneurysm and Aneurysm, Ruptured, sponsored by Bolton Medical.
NCT03214601 is a NA study of Aortic Aneurysm and Aneurysm, Ruptured that is active but no longer recruiting, run by Bolton Medical. The registered enrollment target is 30 participants, below the 638-participant average among 14 other Aortic Aneurysm trials with a reported enrollment target (95% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03214601, a NA study of Aortic Aneurysm and Aneurysm, Ruptured, is active but no longer recruiting, sponsored by Bolton Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device. This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at the index procedure and at 30-day follow-up. The study will evaluate the delivery and deployment of the device, patency of branches and branch vessels, and exclusion of the aortic pathology. The data will help determine if modifications need to be made to the device, the procedural steps, operator technique, or the indications for use.
Primary Outcome
The primary safety outcome determined by the rate of MAEs, including * All-cause mortality * Disabling stroke: a Modified Rankin Score (mRS) of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-stroke baseline * Permanent Paralysis/Paraparesis * Spontaneous Myocardial Infarction according to the SCAI definition * Renal Failure * Procedural Blood Loss \>1,000mL
Conditions Studied
Interventions
- DEVICE penetrating atherosclerotic ulcer, aorta branch cardiovascular implant
Study Locations (12)
Texas
- Baylor College of Medicine - Houston
- Baylor Scott and White Research Institute - Plano
California
- University of Southern California - Los Angeles
Florida
- University of Florida - Gainesville
Georgia
- Emory University - Atlanta
Maryland
- University of Maryland - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Missouri
- Barnes Jewish Hospital at Washington University - St Louis
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2028-08-31 |
| Phase | NA |
What the registry record for NCT03214601 still lists
NCT03214601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 638-participant average among 14 other Aortic Aneurysm trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Aortic Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which penetrating atherosclerotic ulcer, aorta branch cardiovascular implant is the first listed.
NCT03214601 lists 12 locations in 11 states (Texas, California, Florida).
Frequently Asked Questions
What is clinical trial NCT03214601 about?
NCT03214601 is a clinical study titled "Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System". The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device. This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at the index procedure a...
What is the current status of trial NCT03214601?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2017-12-04. Estimated completion is 2028-08-31.
What conditions does trial NCT03214601 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Aneurysm, Ruptured, Thoracic Aorta Aneurysm.
What interventions are being tested in trial NCT03214601?
The interventions under investigation include: penetrating atherosclerotic ulcer, aorta branch cardiovascular implant (DEVICE).
Who is sponsoring clinical trial NCT03214601?
This trial is sponsored by Bolton Medical, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03214601 being conducted?
This trial has 12 study locations across California, Florida, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03214601's enrollment target sits among peer trials
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