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Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System
NCT03214601 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03214601
The ClinicalTrials.gov registry entry for NCT03214601 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bolton Medical, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03214601 reports 12 study locations spanning 11 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03214601?
The interventions under investigation include: penetrating atherosclerotic ulcer, aorta branch cardiovascular implant (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03214601?
This trial is sponsored by Bolton Medical, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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