An observational study in Aortic Aneurysm and Dissection, sponsored by Vascutek Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Vascutek Ltd. (part of Terumo Corporation) · Observational
This prospective, non-interventional, study of Thoraflex Hybrid devices is part of Terumo Aortic's clinical development and Post Market Clinical Follow-Up (PMCF) plan and will provide insights into both the short- and long-term clinical outcomes of all commercially available Thoraflex Hybrid devices.
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 117 observational studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm 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.
Compared within Aortic Aneurysm, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aortic Dissection. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with damaged or diseased aortic arch and descending aorta in cases such as aneurysm and dissection, with or without involvement of the ascending aorta, who undergo treatment with a Thoraflex Hybrid device.
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.
Ability to provide
Retrospective consent will be permitted in some circumstances. In the event the patient was not consented prior to procedure (e.g., due to admission type or study site personnel availability at the time of pre-procedure), consent may be collected retrospectively immediately after procedure and no later than discharge
o Where retrospective consent is used, no data will be collected in the study electronic data capture (EDC) prior to written informed consent being obtained
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aortic repair with Thoraflex Hybrid device.
Also known as: Frozen Elephant Trunk, Hybrid Aortic Repair
Primary Endpoint
The primary endpoint is a composite endpoint defined as the absence of the following events through 12-months post-procedure: * All-cause mortality * Aortic rupture in the treated segment * Unanticipated device-related secondary intervention (endovascular or open surgical)
Time frame: 1 year
Individual Components of Primary Endpoint: All-cause mortality
Rate of all-cause mortality
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from discharge/30 days through to completion of follow up (approx. 10 years).
Individual Components of Primary Endpoint: Aortic rupture in the treated segment
Rate of aortic rupture in the treated segment
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Individual Components of Primary Endpoint: Unanticipated device-related secondary intervention (endovascular or open surgical)
Rate of unanticipated device-related secondary intervention (endovascular or open surgical)
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Major Adverse Events: Stroke
Rate of Stroke of any type, including transient ischemia attack (TIA)
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Major Adverse Events: Myocardial Infarction (MI)
Rate of Myocardial Infarction (MI)
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Major Adverse Events: Paraplegia/Paraparesis
Rate of Paraplegia/Paraparesis
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Major Adverse Events: Respiratory Failure
Rate of Respiratory Failure
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Major Adverse Events: Renal Failure
Rate of Renal Failure
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Major Adverse Events: Bowel Ischemia
Rate of Bowel Ischemia
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Dissection Endpoints: Entry Flow Type
Entry Flow (Type I, Type II and Type R)
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Dissection Endpoints: Remodelling
Positive aortic remodelling in the treated segment(s), defined as either: * false lumen reduction in maximal diameter or volume and no growth in total aortic diameter or volume * true lumen expansion in maximal diameter or volume and no growth in total aortic diameter or volume; or * total aortic maximal diameter reduction with variable changes in true and false lumen diameters.
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Clinical Utility Measures
Procedure time (hours)
Time frame: Perioperative
Clinical Utility Measures
Time in the Intensive Care Unit (ICU) (days)
Time frame: Discharge/30 days
Clinical Utility Measures
Time in Hospital (days)
Time frame: Discharge/30 days
Technical Success
Technical Success is a composite endpoint evaluated at the index procedure by the implanting physician and is defined as follows: * Successful access to the arterial system * Successful delivery and accurate placement of the implant in the planned location without unplanned vessel coverage * Absence of device deformations requiring unplanned placement of an additional device (at the index procedure) * Patency of the implant (including branches) without significant twist, kinks or obstruction * Successful retrieval of the device delivery system (without unanticipated corrective action related to the withdrawal) * No need for unanticipated corrective intervention or emergency surgery to achieve the above goals Technical success can include the use of additional modular components, stents, or angioplasty and adjunctive surgical procedures at the time of the primary procedure.
Time frame: Day 1
Lesion- and/or device-related secondary intervention
Rate of lesion- and/or device-related secondary intervention
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Lesion related mortality
Rate of Lesion-related mortality
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Intraluminal Thrombosis (ILT)
Rate of Intraluminal Thrombosis (ILT)
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Device occlusion
Rate of Device occlusion
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Device infection
Rate of device infection
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
New aortic dissection
Incidence of new aortic dissection
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Device migration
Device migration (\>10mm movement of stented portion of the implant)
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
All endoleaks
Rate of all endoleaks
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Aortic expansion
Rate of aortic expansion (increase of \>5mm in diameter \[of the treated aortic segment\] when compared with the first post-procedural imaging)
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Fistula formation
Rate of fistula formation
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Pseudoaneurysm in the treated segment
Rate of pseudoaneurysm in the treated segment
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
Loss of device integrity
Loss of device integrity (i.e., stent fractures, device kinking, device twisting)
Time frame: The secondary endpoints will be measured at each standard of care follow-up timepoint from the procedure/Day 1 through to completion of follow up (approx. 10 years).
No study locations are listed for this record.
Start is estimated for May 2027; primary completion for May 2039, 144 months later.
Of 44 observational studies under Aortic Aneurysm, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 107. This study's planned 144 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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