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Active, not recruiting No phase listed Observational

Thoraflex Hybrid and Relay Extension Post-Approval Study

ClinicalTrials.gov ID: NCT05639400

Public ClinicalTrials.gov record NCT05639400. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 2:08 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site. Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.

Study identification

NCT ID
NCT05639400
Recruitment status
Active, not recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Vascutek Ltd.
Industry
Enrollment
352 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 17, 2023 (Actual)
Primary completion
Jul 2035 (Estimated)
Completion
Mar 2036 (Estimated)
Last update posted
Feb 6, 2026

2023 – 2036

United States locations

U.S. sites
18
U.S. states
15
U.S. cities
17
Facility City State ZIP Site status
University of Alabama in Birmingham Medical Center Birmingham Alabama 35294 —
Cedars-Sinai Medical Centre Los Angeles California 90048 —
Keck Medical Centre of USC Los Angeles California 90089 —
University of Colorado Aurora Colorado 80045 —
Hartford Hospital Hartford Connecticut 06106 —
Medstar Washington Hospital Centre Washington D.C. District of Columbia 20010 —
Northwestern University Chicago Illinois 60611 —
Ascension St. Vincent Heart Center Indianapolis Indiana 46290 —
University of Maryland Baltimore Maryland 21201 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Washington University/Barnes Jewish Hospital St Louis Missouri 63110 —
Weill Cornell medicine New York New York 10065 —
Duke University Medical Centre Durham North Carolina 27710 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
UPMC Presbyterian Pittsburgh Pennsylvania 15213 —
UT Dell Medical / Ascension Texas Cardiovascular Austin Texas 78705 —
Baylor College of Medicine - St. Luke's Houston Texas 77030 —
University of Utah Salt Lake City Utah 84132 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05639400, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 6, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05639400 live on ClinicalTrials.gov.

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