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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 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.

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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.

Conditions Studied

Aortic Aneurysm Aneurysm, Ruptured Thoracic Aorta Aneurysm

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

FieldValue
Enrollment Target 30 participants
Start Date 2017-12-04
Est. Completion 2028-08-31
Phase NA

Sponsor

Bolton Medical

10 total trials

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What the Registry Record Tells You About NCT03214601

The ClinicalTrials.gov registry entry for NCT03214601 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 638-participant average among 14 other Aortic Aneurysm trials with a reported enrollment target (95% lower). The listed sponsor is Bolton Medical, which has 10 total studies on file at ClinicalTrials.gov.

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 reports 12 study locations spanning 11 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.