Hemodynamic Changes in the Aorta After Endovascular Treatment of the Aortic Dissection

NCT ID: NCT03669055

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-07
• Study Completion Date: 2020-02-06

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.

Conditions

Aortic Dissection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pre-operative and post operative Magnetic Resonance Imaging

Realization of an angio-MRI with 4D phase contrast sequence before and after the endovascular treatment of the aortic dissection

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: OTHER

Realization of a MRI before and after the endovascular treatment of the aortic dissection. Use of the 4D phase-contrast sequence during the MRI.

Interventions

Magnetic Resonance Imaging

Realization of a MRI before and after the endovascular treatment of the aortic dissection. Use of the 4D phase-contrast sequence during the MRI.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Louis Pradel

Bron, , France

Countries

France

Other Identifiers

2018-A01742-53

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_0361

Identifier Type: -

Identifier Source: org_study_id