Clinical trial NCT03669055: Hemodynamic Changes in the Aorta After Endovascular Treatment of the Aortic Dissection
Official title: Radiological Study of the Hemodynamic Changes in the Aorta and Its Branches Before and After Endovascular Treatment of the Aortic Dissection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Dissection
Keywords: aortic dissection
hemodynamic
4D flow phase contrast MRI
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparative measurement of the flow in the aortic true lumen before and after endovascular treatment of the aortic dissection
timeFrame: change from day 0 and day 16
Secondary outcomes:
measure: Comparative measurement of the flow in the aortic false lumen before and after endovascular treatment of the aortic dissection
timeFrame: change from day 0 and day 16
measure: Comparative measurement of the flow in the aortic branches before and after endovascular treatment of the aortic dissection
timeFrame: day 0 and day 16
measure: 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
timeFrame: change from day 0 and day 16
measure: Flow measurement through intimal tear with 4 Dimensions (4D) phase-contrast MRI before and after endovascular treatment of the aortic dissection
timeFrame: change from day 0 and day 16
measure: Comparative measurement through 4D phase-contrast MRI of the shear forces before and after endovascular treatment of the aortic dissection
timeFrame: change from day 0 and day 16
measure: Comparative measurement through 4D phase-contrast MRI of parietal energy before and after endovascular treatment of the aortic dissection
timeFrame: change from day 0 and day 16
measure: Comparative measurement through 4D phase-contrast MRI of the presence of helicoidal flow before and after endovascular treatment of the aortic dissection
timeFrame: change from day 0 and day 16
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Louis Pradel
Study officials:
References: