Thoracic DiseasesEXTENDNCT05639400
Thoraflex Hybrid and Relay Extension Post-Approval Study
An observational study of Thoracic Diseases and Aortic Aneurysm, run by Vascutek Ltd. at 27 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Diseases, Aortic Aneurysm, Aortic Dissection
- What is being tested?
- Thoraflex Hybrid and RelayPro NBS
- Type of treatment
- Medical device
- How many people
- 352 participants
- Where
- 27 sitesin 7 countries
- Study dates
- 17 Mar 2023to Mar 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
27 sites in 7 countries.
27 sites in 7 countries
United States18 sites
University of Colorado
Aurora, Colorado, 80045
UT Dell Medical / Ascension Texas Cardiovascular
Austin, Texas, 78705
University of Maryland
Baltimore, Maryland, 21201
University of Alabama in Birmingham Medical Center
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
Duke University Medical Centre
Durham, North Carolina, 27710
Hartford Hospital
Hartford, Connecticut, 06106
Baylor College of Medicine - St. Luke's
Houston, Texas, 77030
Ascension St. Vincent Heart Center
Indianapolis, Indiana, 46290
Cedars-Sinai Medical Centre
Los Angeles, California, 90048
Keck Medical Centre of USC
Los Angeles, California, 90089
Weill Cornell medicine
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
University of Utah
Salt Lake City, Utah, 84132
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110
Medstar Washington Hospital Centre
Washington D.C., District of Columbia, 20010
United Kingdom3 sites
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, BS2 8HW
Oxford University Hospitals NHS FT
Oxford, OX3 9DU
Southampton General Hospital
Southampton, SO16 6YD
France2 sites
CHU Nantes
Saint-Herblain
CHU de Toulouse - Hôpital de Rangueil
Toulouse, 31059
About this study
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
- Thoracic Diseases, Aortic Aneurysm, Aortic Dissection, Thoracic Aortic Aneurysm, Thoracic Aortic Dissection
- Being tested
- Thoraflex Hybrid, RelayPro NBS
- Keywords
- TEVAR, Frozen Elephant Trunk (FET)
- Medical subject headings
- Thoracic Diseases, Aortic Aneurysm, Aortic Dissection, Aortic Aneurysm, Thoracic, Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoraflex HybridDevice
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 NBSDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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
Measured: 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
- All-cause mortality, and
- 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))
- All/any paraplegia/paraparesis defined as SCI (SVS grades 1 to 3)
- Any stroke (excluding TIA)
- Incidence of Myocardial Infarction
- Incidence of Respiratory Failure
- Incidence of Renal Failure
- Incidence of Bowel Ischemia
Measured: 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
- Any aortic rupture (treated and untreated segments)
- Aortic remodeling in the treated segment(s)
- New dissections
- Proximal and distal extension of dissections
- Any false lumen perfusion (specifying location and if intentional or not)
- Fistula formation
- All endoleaks
- Device migration (measure both >5mm from position at discharge/within 30 days, and >10 mm from position at discharge/within 30 days, and requiring secondary intervention)
- Device integrity issues (e.g., stent fracture)
- All thromboembolic events
- Pseudoaneurysms (device-related)
- Secondary Interventions
- Graft patency (loss of patency will be defined as an opening of <50% due to, for example, occlusion, stenosis, kinking)
Measured: The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start17 Mar 2023
- Primary completionJul 2035 (estimated)
- Study completionMar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bolton Medical
- Responsible party
- Sponsor
- Investigators
- Martin Czerny, Principal investigator, University of FreiburgJoseph E Bavaria, Principal investigator, Jefferson Health and Sidney Kimmel Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639400
- Sponsor's protocol ID
- EXTEND-001
- Acronym
- EXTEND
- Status last verified
- Feb 2026
- First submitted
- 24 Nov 2022
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoraflex Hybrid and Relay Extension Post-Approval Study
- ClinicalTrials.gov ID
- NCT05639400
- Acronym / sponsor ID
- EXTEND / EXTEND-001
- Conditions
- Thoracic Diseases, Aortic Aneurysm, Aortic Dissection, Thoracic Aortic Aneurysm, Thoracic Aortic Dissection
- Keywords
- TEVAR, Frozen Elephant Trunk (FET)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Bolton Medical
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- Jul 2035 (estimated)
- Study completion
- Mar 2036 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoraflex HybridThoraflex 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). | Device | – |
| RelayPro NBSThe 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. | Device | – |
Primary outcome
Primary Safety Endpoint is a composite of the following:
Time frame: 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.
* 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.)
Primary Effectiveness Endpoint: Treatment Success
Time frame: 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.
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
2 secondary outcomes
Secondary Safety Endpoints, Absence of the following
Time frame: 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
Time frame: The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Czerny principal investigator
University of Freiburg
Joseph E Bavaria principal investigator
Jefferson Health and Sidney Kimmel Medical College
27 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Diseases and Aortic Aneurysm, run by Vascutek Ltd. at 27 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, United Kingdom, France, Austria, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint is a composite of the following: (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.