Thoraflex Hybrid and Relay Extension Post-Approval Study

NCT05639400 | Active Not Recruiting DMC FDA Device

• 1 other identifier: EXTEND-001
• Study Type: observational
• Target: 352
• Locations: 7 countries
• Sites: 27

Brief Summary

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.

Conditions

Aortic Aneurysm; Aortic Dissection; Thoracic Aortic Aneurysm; Thoracic Diseases; Thoracic Aortic Dissection

Keywords

TEVAR; Frozen Elephant Trunk (FET)

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint is a composite of the following:

  * Permanent disabling stroke (mRS \>2 and an increase in at least one mRS category from the individual's pre-stroke baseline, occurring within 30 days of either index procedure or extension and present at 1-year follow-up)\* Note: If a subject dies prior to 1-year follow-up, their last recorded mRS will be considered their final score * Grade 3 spinal cord ischemia (SVS reporting standards) occurring within 30 days of either index procedure or extension * All-cause mortality (within 1 year of either procedure) (\*Per VARC-3, disability assessment using the mRS should be performed between 30 and 90 days after a neurological event with 90 days being optimal. An increased mRS score by itself and in the absence of a neurological event does not constitute stroke.)

  The primary safety endpoint will be measured at one-year after the index procedure and again at least 8 months after the (first) extension procedure.

• Primary Effectiveness Endpoint: Treatment Success

  Defined as device technical success (of either procedure) with absence of the following at 1-year: * Lesion-related mortality (defined as all deaths occurring within 30 days of, or, prior to discharge, from either the index procedure or the extension procedure or any revision procedures to treat the original lesion(s) and any other deaths adjudicated by Clinical Events Committee as related or probably related to the lesion(s)) * Aortic rupture in the treated segment * Lesion expansion (≥5mm increase from measurement at discharge/within 30 days) * Secondary intervention to address the following: * Stent graft-induced aortic wall injury (SAWI) * Fistula * Type I or III endoleak (see definitions) * Migration * Loss of Patency * Thromboembolic events * Failure of integrity

  The primary effectiveness endpoint will be measured at one-year after the index procedure and again at least 8 months after the (first) extension procedure.

Secondary Outcomes (2)

• Secondary Safety Endpoints, Absence of the following

  The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years.

• Secondary effectiveness endpoints will be reported

  The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years.

Interventions

Thoraflex Hybrid DEVICE

Thoraflex Hybrid is designed for the open surgical repair of aneurysms and/or dissections in the aortic arch and descending aorta with or without involvement of the ascending aorta. There are two types of Thoraflex Hybrid implants, namely the Plexus 4 and the Ante-Flo versions. Each patient receives one Thoraflex Hybrid device (either the Plexus 4 or Ante-Flo).

RelayPro NBS DEVICE

The RelayPro NBS Thoracic Stent-Graft System is an endovascular device intended for treatment of thoracic aortic pathologies such as aneurysms, pseudoaneurysms, dissections, penetrating ulcers and intramural hematoma.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft.

You may qualify if:

• Patient is aged 18 years or older on date of consent. Patient is willing and able to comply with all study procedures and visits. Patient or their next of kin (NOK)/legally designated representative (LDR) has given written informed consent to participate in the study.
• Patient will undergo treatment with a Thoraflex Hybrid device. If a patient requires an extension procedure due to the extent of aortic disease, a RelayPro NBS Stent-graft should be placed inside the distal end of the previously placed Thoraflex Hybrid device via a retrograde approach. This may be part of the same or a two-stage procedure.

You may not qualify if:

• Patient has any medical, social, or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure.

Sponsors & Collaborators

• Vascutek Ltd.: lead
• Bolton Medical: collaborator

Study Sites (27)

University of Alabama in Birmingham Medical Center

Birmingham, Alabama, 35294, United States

Location

Cedars-Sinai Medical Centre

Los Angeles, California, 90048, United States

Location

Keck Medical Centre of USC

Los Angeles, California, 90089, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Medstar Washington Hospital Centre

Washington D.C., District of Columbia, 20010, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Ascension St. Vincent Heart Center

Indianapolis, Indiana, 46290, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Weill Cornell medicine

New York, New York, 10065, United States

Location

Duke University Medical Centre

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

UT Dell Medical / Ascension Texas Cardiovascular

Austin, Texas, 78705, United States

Location

Baylor College of Medicine - St. Luke's

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Paracelsus Medical University

Salzburg, 5020, Austria

Location

CHU Nantes

Saint-Herblain, France

Location

CHU de Toulouse - Hôpital de Rangueil

Toulouse, 31059, France

Location

University of Freiburg

Freiburg im Breisgau, Germany

Location

Policlinico Di S.Orsola, Universita' Di Bologna

Bologna, 9 40138, Italy

Location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, BS2 8HW, United Kingdom

Location

Oxford University Hospitals NHS FT

Oxford, OX3 9DU, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Thoracic Diseases; Aortic Aneurysm; Aortic Dissection; Aortic Aneurysm, Thoracic; Dissection, Thoracic Aorta

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Officials

• Martin Czerny

  University of Freiburg

  PRINCIPAL INVESTIGATOR

• Joseph E Bavaria

  Jefferson Health and Sidney Kimmel Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 6, 2022
• Study Start: March 17, 2023
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): March 1, 2036
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

DE (1); US (18); GB (3); AU (1); FR (2); ES (1); IT (1)