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

NCT03669055 | Completed

• 2 other identifiers: 69HCL18_03612018-A01742-53
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

aortic dissection; hemodynamic; 4D flow phase contrast MRI

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  change from day 0 and day 16

Study Arms (1)

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

Other: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging 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.

Pre-operative and post operative Magnetic Resonance Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital Louis Pradel

Bron, France

Location

MeSH Terms

Conditions

Aortic Dissection

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: September 13, 2018
• Study Start: March 7, 2019
• Primary Completion: February 6, 2020
• Study Completion: February 6, 2020
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)