Aortic Aneurysm and DissectionCHEETAHNCT07911163
Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
An observational study of Aortic Aneurysm and Dissection, run by Vascutek Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm and Dissection
- What is being tested?
- Thoraflex Hybrid
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2027to May 2039
- How long will I take part?
- 10 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patient is aged 18 years or older on date of consent
- Indication for open surgical repair using a Thoraflex Hybrid graft
- Ability to provide informed consent
- 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
- If the subject is unable to provide consent (for example, in emergency treatment; or if they are 18 years old but do not meeting the minimum legal age for informed consent in their region), then the consent of their /legally designated representative (LDR)/legally authorized representative (LAR) is permitted (dependent on local IEC/IRB approvals).
- Willingness to comply with standard of care follow-up visits
Who cannot join
- Patient is unable or unwilling to comply with standard of care follow-up regimen
- Patient is contraindicated per the instructions for use (IFU)
- Patient has any other medical, social or psychological condition which, in the opinion of the Investigator, could compromise the patient's ability to comply with study evaluations (as outlined in the protocol)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Study Mailbox contact
About this study
Official title: Clinical HEalth Outcomes Evaluation of Terumo Aortic Hybrid Devices
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.
- Conditions
- Aortic Aneurysm and Dissection
- Being tested
- Thoraflex Hybrid
- Keywords
- Thoraflex Hybrid, Aortic Aneurysm, Aortic Dissection
- Medical subject headings
- Aortic Dissection, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoraflex HybridDevice
Also called Frozen Elephant Trunk, Hybrid Aortic Repair
Aortic repair with Thoraflex Hybrid device.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (27)
Individual Components of Primary Endpoint: All-cause mortality
Rate of all-cause mortality
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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)
Measured: Perioperative
Clinical Utility Measures
Time in the Intensive Care Unit (ICU) (days)
Measured: Discharge/30 days
Clinical Utility Measures
Time in Hospital (days)
Measured: 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.
Measured: Day 1
Lesion- and/or device-related secondary intervention
Rate of lesion- and/or device-related secondary intervention
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startMay 2027 (estimated)
- Primary completionMay 2039 (estimated)
- Study completionMay 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm and DissectionStudies 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
- 150 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911163
- Sponsor's protocol ID
- CHEETAH-001
- Acronym
- CHEETAH
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical HEalth Outcomes Evaluation of Terumo Aortic Hybrid Devices
- ClinicalTrials.gov ID
- NCT07911163
- Acronym / sponsor ID
- CHEETAH / CHEETAH-001
- Conditions
- Aortic Aneurysm and Dissection
- Keywords
- Thoraflex Hybrid, Aortic Aneurysm, Aortic Dissection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2027 (estimated)
- Primary completion
- May 2039 (estimated)
- Study completion
- May 2039 (estimated)
- First posted
- 2 Nov 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- Patient is aged 18 years or older on date of consent
- Indication for open surgical repair using a Thoraflex Hybrid graft
- Ability to provide informed consent
- 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
- Willingness to comply with standard of care follow-up visits
Key exclusion criteria (3 listed)
- Patient is unable or unwilling to comply with standard of care follow-up regimen
- Patient is contraindicated per the instructions for use (IFU)
- Patient has any other medical, social or psychological condition which, in the opinion of the Investigator, could compromise the patient's ability to comply with study evaluations (as outlined in the protocol)
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 HybridAlso: Frozen Elephant Trunk, Hybrid Aortic RepairAortic repair with Thoraflex Hybrid device. | Device | – |
Primary outcome
Primary Endpoint
Time frame: 1 year
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)
27 secondary outcomes
Individual Components of Primary Endpoint: 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
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)
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
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)
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
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
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
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
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
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
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
Time frame: Perioperative
Clinical Utility Measures
Time frame: Discharge/30 days
Clinical Utility Measures
Time frame: Discharge/30 days
Technical Success
Time frame: Day 1
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
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)
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
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
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
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
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
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
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
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
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
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).
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 2 Nov 2026.
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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.
Study Mailbox contact
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Dissection, run by Vascutek Ltd..
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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Clinical Study Manager (+441418125555, r.smith1@terumoaortic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 1 year). 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 2 Nov 2026.