Acute Aortic DissectionTHORNCT03414866
Thoraflex Hybrid Post-Market Study
An observational study of Acute Aortic Dissection and Aortic Rupture, run by Vascutek Ltd. at 7 sites in 4 countries.
Trial summary
This is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic aneurysm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Aortic Dissection, Aortic Rupture, Penetrating Aortic Ulcer
- What is being tested?
- EQ-5D-5L QOL questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 182 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 25 May 2018to Jul 2026
- 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: 60 patients with acute thoracic aortic syndrome, including: acute dissection, aortic rupture and penetrating aortic ulcer (PAU) 60 patients with a subacute/chronic dissection of the aorta 60 patients with an aortic aneurysm
Who may be able to join
- Patient is aged 18 years or over on date of consent
- Patient is willing and able to comply with all study procedures and study visits
- Patient or their legally authorised representative (LAR) has given written informed consent to participate in study. For emergency patients only, retrospective consent is permissible
- Patient satisfies the inclusion criteria for one of the following categories:
- A - Patient has acute thoracic aortic syndrome or B - Patient has subacute/ chronic dissection of the aorta or C - Patient has an aortic aneurysm (including connective tissue disorders)
- Patients with acute thoracic aortic syndrome:
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- Patient has acute thoracic aortic syndrome and requires repair or replacement of damaged or diseased vessels of the aortic arch (with or without involvement of the ascending aorta), and the descending aorta requires replacement, or, in the opinion of the investigator, the patient would derive clinical benefit from prophylactic treatment of the descending aorta. This includes patients with acute dissections, rupture of the aorta or PAU.
- Patients with subacute/chronic dissection of the aorta:
- Patient requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta due to subacute/chronic dissection.
- And patient satisfies one or more of the following criteria:
- Patient has aortic sinus, or ascending aorta, or aortic arch, or descending aorta diameter ≥5.5cm (including if asymptomatic) or
- Patient has aorta diameter <5.5cm and growth rate ≥0.5cm/year (including if asymptomatic) or
- Patient has ascending aorta diameter ≥4.5cm and requires valve repair or replacement
- Patients with an aortic aneurysm (including connective tissue disorders):
- Patient requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta
- And patient satisfies one or more of the following criteria:
- Patient has aortic sinus, or ascending aorta, or aortic arch, or descending aorta diameter ≥5.5cm (including if asymptomatic) or
- Patient has aorta diameter <5.5cm and growth rate ≥0.5cm/year (including if asymptomatic) or
- Patient has ascending aorta diameter ≥4.5cm and requires valve repair or replacement.
- or
- Patient has Marfan syndrome or other genetically mediated disorders with aortic sinus, or ascending aorta, or arch diameter ≥4.5cm, or, the ratio of the maximal ascending or aortic root area (Π r2) in cm2 divided by the patient's height in meters exceeds 10
Who cannot join
- Patient is unfit for open surgical repair involving circulatory arrest
- Patient has known sensitivity to polyester, nitinol or materials of bovine origin
- Patient has active endocarditis or an active infective disorder of the aorta
- Patient has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
- Patient is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study, which in the opinion of the Investigator will impact on this study
- Patient has an uncorrectable bleeding anomaly
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- Patient has renal failure (defined as dialysis dependent)
- Patient has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated
- Patient has a co-morbidity causing expected survival to be less than 1 year
- Patient has any other 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
7 sites in 4 countries.
7 sites in 4 countries
Canada3 sites
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5
University of Ottawa Heart Institute
Ottawa, Ontario
Toronto General Hospital
Toronto, Ontario
Germany2 sites
University of Freiburg
Freiburg im Breisgau
Hannover Medical School
Hanover, 30625
About this study
This is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic aneurysm.
Read the detailed description
Aortic arch pathologies are rare, but pose significant challenges for treatment involving open surgical or endovascular repair.
In 1983 the Elephant Trunk technique was introduced and has greatly facilitated the management of patients with extensive thoracic aortic disease.
In recent years, this traditional open surgery has been combined with thoracic endovascular repair (TEVAR) and this is known as the 'hybrid' approach. Hybrid repairs, consisting of an open surgical repair combined with endovascular techniques.
Further advancement in the types of prosthesis available has resulted in the evolution of the conventional ET technique into the frozen elephant trunk (FET) technique. This utilises devices that incorporate both a traditional dacron graft (for open surgical treatment of the aortic arch) and a stented graft portion (for treatment of the descending thoracic aorta). The stented portion of the graft is introduced via an antegrade approach through the transected arch. The FET technique is now commonly used to treat patients with extensive thoracic or thoraco-abdominal aortic disease.
Vascutek Ltd has developed the Thoraflex™ Hybrid Device (Plexus™ 4 and Ante-Flo™) for the repair or replacement of damaged or diseased vessels of the ascending aorta, aortic arch and descending thoracic aorta in cases of aneurysm and/or dissection. The Thoraflex™ Hybrid Device is one of the commercially available frozen elephant trunk prosthesis.
Over 3000 Thoraflex™ Hybrid Devices have been sold and the current study seeks to provide further evidence of the continuing safety and effectiveness of the device.
- Conditions
- Acute Aortic Dissection, Aortic Rupture, Penetrating Aortic Ulcer, Aortic Dissection, Aortic Aneurysm, Thoracic
- Being tested
- EQ-5D-5L QOL questionnaire
- Keywords
- Thoracic Aorta, Dissection, Aneurysm, Frozen Elephant Trunk
- Medical subject headings
- Aortic Rupture, Penetrating Atherosclerotic Ulcer, Aortic Dissection, Aortic Aneurysm, Thoracic, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ-5D-5L QOL questionnaireBehavioural
Written questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Acute thoracic aortic syndrome | 60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire Receives: Behavioral: EQ-5D-5L QOL questionnaire | |
| Subacute/chronic dissection of the aorta | 60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire Receives: Behavioral: EQ-5D-5L QOL questionnaire | |
| Aortic aneurysm | 60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire Receives: Behavioral: EQ-5D-5L QOL questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Major Adverse Event
The primary endpoint will be freedom from the following composite Major Adverse Event (MAE): permanent stroke , permanent paraplegia/paraparesis, unanticipated aortic related re-operation (excluding re-operation for bleeding) and aortic related mortality
Measured: 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start25 May 2018
- Primary completion25 Apr 2025
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Aortic 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
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Malakh Shrestha, Prof. Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414866
- Sponsor's protocol ID
- THOR-001
- Acronym
- THOR
- Status last verified
- Jul 2025
- First submitted
- 23 Jan 2018
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoraflex Hybrid Post-Market Study
- ClinicalTrials.gov ID
- NCT03414866
- Acronym / sponsor ID
- THOR / THOR-001
- Conditions
- Acute Aortic Dissection, Aortic Rupture, Penetrating Aortic Ulcer, Aortic Dissection, Aortic Aneurysm, Thoracic
- Keywords
- Thoracic Aorta, Dissection, Aneurysm, Frozen Elephant Trunk
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 May 2018 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 30 Jan 2018 (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 is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic aneurysm.
Detailed description
Aortic arch pathologies are rare, but pose significant challenges for treatment involving open surgical or endovascular repair.
In 1983 the Elephant Trunk technique was introduced and has greatly facilitated the management of patients with extensive thoracic aortic disease.
In recent years, this traditional open surgery has been combined with thoracic endovascular repair (TEVAR) and this is known as the 'hybrid' approach. Hybrid repairs, consisting of an open surgical repair combined with endovascular techniques.
Further advancement in the types of prosthesis available has resulted in the evolution of the conventional ET technique into the frozen elephant trunk (FET) technique. This utilises devices that incorporate both a traditional dacron graft (for open surgical treatment of the aortic arch) and a stented graft portion (for treatment of the descending thoracic aorta). The stented portion of the graft is introduced via an antegrade approach through the transected arch. The FET technique is now commonly used to treat patients with extensive thoracic or thoraco-abdominal aortic disease.
Vascutek Ltd has developed the Thoraflex™ Hybrid Device (Plexus™ 4 and Ante-Flo™) for the repair or replacement of damaged or diseased vessels of the ascending aorta, aortic arch and descending thoracic aorta in cases of aneurysm and/or dissection. The Thoraflex™ Hybrid Device is one of the commercially available frozen elephant trunk prosthesis.
Over 3000 Thoraflex™ Hybrid Devices have been sold and the current study seeks to provide further evidence of the continuing safety and effectiveness of the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute thoracic aortic syndrome | – | Behavioral: EQ-5D-5L QOL questionnaire60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire |
| Subacute/chronic dissection of the aorta | – | Behavioral: EQ-5D-5L QOL questionnaire60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire |
| Aortic aneurysm | – | Behavioral: EQ-5D-5L QOL questionnaire60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients with acute thoracic aortic syndrome, including: acute dissection, aortic rupture and penetrating aortic ulcer (PAU) 60 patients with a subacute/chronic dissection of the aorta 60 patients with an aortic aneurysm
Key inclusion criteria (21 listed)
- Patient is aged 18 years or over on date of consent
- Patient is willing and able to comply with all study procedures and study visits
- Patient or their legally authorised representative (LAR) has given written informed consent to participate in study. For emergency patients only, retrospective consent is permissible
- Patient satisfies the inclusion criteria for one of the following categories:
- A - Patient has acute thoracic aortic syndrome or B - Patient has subacute/ chronic dissection of the aorta or C - Patient has an aortic aneurysm (including connective tissue disorders)
Key exclusion criteria (10 listed)
- Patient is unfit for open surgical repair involving circulatory arrest
- Patient has known sensitivity to polyester, nitinol or materials of bovine origin
- Patient has active endocarditis or an active infective disorder of the aorta
- Patient has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
- Patient is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study, which in the opinion of the Investigator will impact on this study
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 |
|---|---|---|
| EQ-5D-5L QOL questionnaireWritten questionnaire | Behavioural | Acute thoracic aortic syndrome, Aortic aneurysm, Subacute/chronic dissection of the aorta |
Primary outcome
Freedom from Major Adverse Event
Time frame: 1 year post-procedure
The primary endpoint will be freedom from the following composite Major Adverse Event (MAE): permanent stroke , permanent paraplegia/paraparesis, unanticipated aortic related re-operation (excluding re-operation for bleeding) and aortic related mortality
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 9 Jul 2025.
Related trials for Acute Aortic Dissection
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GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
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Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
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Endovascular Treatment of Thoracic Aortic Disease
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Not yet recruiting
A Novel Wire-Reinforced Fenestration of a Hybrid Frozen Elephant Trunk Device for Supra-Aortic Branch Vessel Stenting During Aortic Arch Replacement
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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.
Malakh Shrestha, Prof. Dr. principal investigator
Hannover Medical School
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Aortic Dissection and Aortic Rupture, run by Vascutek Ltd. at 7 sites in 4 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 21 inclusion and 10 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 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Germany, Italy, Netherlands. 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?
Freedom from Major Adverse Event (time frame: 1 year post-procedure). 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 9 Jul 2025.