MedTrace Logo

Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System

NCT03214601 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-31

No results posted yet for this 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

  • Thoracic Aorta Aneurysm
  • Aneurysm, Ruptured
  • Aortic Aneurysm

Interventions

DEVICE

penetrating atherosclerotic ulcer, aorta branch cardiovascular implant

The Relay Branch System is intended to provide an option for patients with arch and proximal descending chronic thoracic aortic pathologies.

Sponsors & Collaborators

  • Bolton Medical

    lead INDUSTRY

Principal Investigators

  • Luis Sanchez, MD · Barnes Jewish Hospital, Washington Univ

  • Wilson Szeto, MD · Penn Presbyterian Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2023-09-18
Completion
2028-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03214601 on ClinicalTrials.gov