Aortic Dissection4DAoNCT03669055
Hemodynamic Changes in the Aorta After Endovascular Treatment of the Aortic Dissection
A study testing Magnetic Resonance Imaging in people with Aortic Dissection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Aortic dissection (AD) is a serious pathology affecting one person for 300 000 habitants per year. In case of complicated AD on the descending aorta, it is necessary to perform an endovascular surgery in association with medical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2019to 6 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients with an aortic dissection requiring endovascular treatment
- The endovascular treatment will be indicated according to the guidelines after medical, radiological and surgical multidisciplinary discussion in our hospital.
- Patients that have signed the informed consent form.
- Members of a social protection scheme.
Who cannot join
- Patients with an aortic dissection requiring an emergency intervention
- Patients with a contra-indication to endovascular treatment
- Contra-indication to MRI: claustrophobia, ferromagnetic materials: pacemaker, prosthetic heart valve, implantable cardioverter defibrillators, vascular clip
- Pregnancy
- Breastfeeding
- Dementia
- Patients under guardianship
- Patients with difficulty in understanding the French language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiological Study of the Hemodynamic Changes in the Aorta and Its Branches Before and After Endovascular Treatment of the Aortic Dissection
Aortic dissection (AD) is a serious pathology affecting one person for 300 000 habitants per year. In case of complicated AD on the descending aorta, it is necessary to perform an endovascular surgery in association with medical treatment. An endoprosthesis is implanted on the descending thoracic aorta in order to close the main intimal tear. This closure lead to an increase in the thoracic true lumen diameter, a decrease in the thoracic false lumen diameter, a better perfusion of the aortic branches. Furthermore, even in case of open surgical treatment of the ascending aorta it can be necessary to perform an endovascular treatment on the descending aorta, either to prevent and treat aneurysmal evolution or to treat patent malperfusion syndrome.
CT and Magnetic Resonance angiography, by the realization of an aortic morphologic evaluation, are the two key imaging exams in the DA. Nevertheless, CT can't provide aortic dynamic evaluation, contrary to MRI. This exam, thanks to the phase-contrast sequence can measure velocity and flow data in vessels, including aorta but also true and false lumen in the AD. Thus, by verifying the perfusion of the aortic true lumen and the aortic branches it is possible to perform an early evaluation of the endovascular treatment of the DA.
Read more
Actually, only one study has realized an aortic dynamic evaluation on the AD, unfortunately this study was limited to non-operated patients.
In order to assess the place of MRI in the AD, the ingestigation propose to determine if phase-contrast MRI is able to evaluate the impact of the endovascular treatment on the hemodynamic state of the aorta and its branches.
- Conditions
- Aortic Dissection
- Being tested
- Magnetic Resonance Imaging
- Keywords
- aortic dissection, hemodynamic, 4D flow phase contrast MRI
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
Realization of a MRI before and after the endovascular treatment of the aortic dissection. Use of the 4D phase-contrast sequence during the MRI.
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative and post operative Magnetic Resonance Imaging | Experimental | Realization of an angio-MRI with 4D phase contrast sequence before and after the endovascular treatment of the aortic dissection Receives: Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative measurement of the flow in the aortic true lumen before and after endovascular treatment of the aortic dissection
The flows are measured in ml/s at several locations of the aortic true lumen. The flows are measured during the two MRI and compared with each other.
Measured: change from day 0 and day 16
Secondary outcomes (7)
Comparative measurement of the flow in the aortic false lumen before and after endovascular treatment of the aortic dissection
The flows are measured in ml/s at several locations of the aortic false lumen. The flows are measured during the two MRI and compared with each other.
Measured: change from day 0 and day 16
Comparative measurement of the flow in the aortic branches before and after endovascular treatment of the aortic dissection
The flows are measured in ml/s in the celiac artery, the superior mesenteric artery, the inferior mesenteric artery, the right and left renal artery, the right and left primitive iliac artery.
The flows are measured during the two MRI and compared with each other.
Measured: day 0 and day 16
Comparative measurement of the number of intimal tear identified through 4D phase-contrast MRI relative to the number of intimal tear identified through Angio MRI before endovascular treatment of the aortic dissection
In the 4D phase-contrast MRI, an intimal tear is identified by a streamline going from the true lumen to the false lumen.
In the Angio MRI, an intimal tear is identified by the visualization of the passage of the contrast agent from the true lumen to the false lumen.
Measured: change from day 0 and day 16
Flow measurement through intimal tear with 4 Dimensions (4D) phase-contrast MRI before and after endovascular treatment of the aortic dissection
The intimal tears are identified thanks to the Angio MRI. The flows are measured during the two MRI and compared with each other.
Measured: change from day 0 and day 16
Comparative measurement through 4D phase-contrast MRI of the shear forces before and after endovascular treatment of the aortic dissection
Shear forces are measured thanks to the 4D phase contrast MRI.
Measured: change from day 0 and day 16
Comparative measurement through 4D phase-contrast MRI of parietal energy before and after endovascular treatment of the aortic dissection
Parietal energy is measured thanks to the 4D phase contrast MRI.
Measured: change from day 0 and day 16
Comparative measurement through 4D phase-contrast MRI of the presence of helicoidal flow before and after endovascular treatment of the aortic dissection
The presence of a perpendicular flow to the main aortic flow is identified thanks to the 4D phase contrast MRI.
The helicoidal flow is quantified by the degree of rotation between the beginning of the end of the cardiac cycle in millisecond.
Measured: change from day 0 and day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start7 Mar 2019
- Primary completion6 Feb 2020
- Study completion6 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669055
- Sponsor's protocol ID
- 69HCL18_0361
- Other IDs
- 2018-A01742-53
- Acronym
- 4DAo
- Status last verified
- Jan 2026
- First submitted
- 30 Jul 2018
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Study of the Hemodynamic Changes in the Aorta and Its Branches Before and After Endovascular Treatment of the Aortic Dissection
- ClinicalTrials.gov ID
- NCT03669055
- Acronym / sponsor ID
- 4DAo / 69HCL18_0361
- Conditions
- Aortic Dissection
- Keywords
- aortic dissection, hemodynamic, 4D flow phase contrast MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 13 Sep 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.
Aortic dissection (AD) is a serious pathology affecting one person for 300 000 habitants per year. In case of complicated AD on the descending aorta, it is necessary to perform an endovascular surgery in association with medical treatment. An endoprosthesis is implanted on the descending thoracic aorta in order to close the main intimal tear. This closure lead to an increase in the thoracic true lumen diameter, a decrease in the thoracic false lumen diameter, a better perfusion of the aortic branches. Furthermore, even in case of open surgical treatment of the ascending aorta it can be necessary to perform an endovascular treatment on the descending aorta, either to prevent and treat aneurysmal evolution or to treat patent malperfusion syndrome.
CT and Magnetic Resonance angiography, by the realization of an aortic morphologic evaluation, are the two key imaging exams in the DA. Nevertheless, CT can't provide aortic dynamic evaluation, contrary to MRI. This exam, thanks to the phase-contrast sequence can measure velocity and flow data in vessels, including aorta but also true and false lumen in the AD. Thus, by verifying the perfusion of the aortic true lumen and the aortic branches it is possible to perform an early evaluation of the endovascular treatment of the DA.
Actually, only one study has realized an aortic dynamic evaluation on the AD, unfortunately this study was limited to non-operated patients.
In order to assess the place of MRI in the AD, the ingestigation propose to determine if phase-contrast MRI is able to evaluate the impact of the endovascular treatment on the hemodynamic state of the aorta and its branches.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-operative and post operative Magnetic Resonance Imaging | Experimental | Other: Magnetic Resonance ImagingRealization of an angio-MRI with 4D phase contrast sequence before and after the endovascular treatment of the aortic dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with an aortic dissection requiring endovascular treatment
- The endovascular treatment will be indicated according to the guidelines after medical, radiological and surgical multidisciplinary discussion in our hospital.
- Patients that have signed the informed consent form.
- Members of a social protection scheme.
Key exclusion criteria (8 listed)
- Patients with an aortic dissection requiring an emergency intervention
- Patients with a contra-indication to endovascular treatment
- Contra-indication to MRI: claustrophobia, ferromagnetic materials: pacemaker, prosthetic heart valve, implantable cardioverter defibrillators, vascular clip
- Pregnancy
- Breastfeeding
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 |
|---|---|---|
| Magnetic Resonance ImagingRealization of a MRI before and after the endovascular treatment of the aortic dissection. Use of the 4D phase-contrast sequence during the MRI. | Other | Pre-operative and post operative Magnetic Resonance Imaging |
Primary outcome
Comparative measurement of the flow in the aortic true lumen before and after endovascular treatment of the aortic dissection
Time frame: change from day 0 and day 16
The flows are measured in ml/s at several locations of the aortic true lumen. The flows are measured during the two MRI and compared with each other.
7 secondary outcomes
Comparative measurement of the flow in the aortic false lumen before and after endovascular treatment of the aortic dissection
Time frame: change from day 0 and day 16
Comparative measurement of the flow in the aortic branches before and after endovascular treatment of the aortic dissection
Time frame: day 0 and day 16
Comparative measurement of the number of intimal tear identified through 4D phase-contrast MRI relative to the number of intimal tear identified through Angio MRI before endovascular treatment of the aortic dissection
Time frame: change from day 0 and day 16
Flow measurement through intimal tear with 4 Dimensions (4D) phase-contrast MRI before and after endovascular treatment of the aortic dissection
Time frame: change from day 0 and day 16
Comparative measurement through 4D phase-contrast MRI of the shear forces before and after endovascular treatment of the aortic dissection
Time frame: change from day 0 and day 16
Comparative measurement through 4D phase-contrast MRI of parietal energy before and after endovascular treatment of the aortic dissection
Time frame: change from day 0 and day 16
Comparative measurement through 4D phase-contrast MRI of the presence of helicoidal flow before and after endovascular treatment of the aortic dissection
Time frame: change from day 0 and day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Aortic Dissection, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparative measurement of the flow in the aortic true lumen before and after endovascular treatment of the aortic dissection (time frame: change from day 0 and day 16). 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 23 Jan 2026.