An observational study in Thoracic Diseases, Aortic Aneurysm and Aortic Dissection, sponsored by Vascutek Ltd.. Active, not recruiting at 27 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Vascutek Ltd. (part of Terumo Corporation) · Observational
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.
72 studies on the registry are indexed under Thoracic Diseases; 13 are open to participants now.
This study's enrollment of 352 is above the median of 122 across 19 observational studies indexed under Thoracic Diseases.
Browse Thoracic Diseases studies →Vascutek Ltd. is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
First submitted after Vascutek Ltd. became part of Terumo Corporation.
Counted across the registry records on this site, refreshed daily.
Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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.
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.)
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.
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
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.
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
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
* 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)
Time frame: The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years.
Plan to share: Undecided
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This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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