EndovaScular Versus mediCaL mAnagement of Uncomplicated Type B Intramural heMatoma Trial (ESCLAIM)

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is a multicenter, open-label and prospective randomized controlled study to compare 1-year outcomes of uncomplicated type B intramural hematoma (IMH) patients undergoing thoracic endovascular aortic repair (TEVAR) plus optimal medical therapy (OMT) with that of those undergoing OMT alone. The primary objective is to test the hypothesis that 1-year aortic-related adverse events are lower in TEVAR plus OMT group than that in OMT alone group. The secondary objective is to test the hypothesis that 1-year all-cause mortality, aortic-related mortality and re-intervention are lower in TEVAR plus OMT group than that in OMT alone group.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Provincial People's Hospital
• Collaborators: First Affiliated Hospital of Xinjiang Medical University; Henan Provincial Chest Hospital; Jiangmen Central Hospital; Jieyang People's Hospital; Shenzhen People's Hospital; The First Affiliated Hospital of Guangzhou Medical University; Wuhan Hanyang Hospital; Xinqiao Hospital of Chongqing

Criteria

Inclusion Criteria:

1. Age >18 years;

2. Be confirmed as Stanford type B IMH by aorta computed tomography;

3. From onset to first clinical attach <90 days;

4. The subject or legal guardian understands the nature of the study and agrees to its;

5. provisions on a written informed consent form;

6. Availability for the appropriate follow-up visits during the follow-up period;

7. Capability to follow all study requirements.

Exclusion Criteria:

1. Persistent or recurrent pain despite full medication,;

2. Hemodynamic instability;

3. Signs of rupture (periaortic hemorrhage);

4. Depth of ULP > 10 mm;

5. Aortic diameter > 55 mm;

6. ULP around with calcification;

7. Previous history of aortic-related procedures;

8. Blunt thoracic aortic injury;

9. Iatrogenic aortic injury;

10. Inherited diseases: Turner syndrome, Marfan syndrome, Ehlers-Danlos syndrome, Loeys Dietz syndrome etc.;

11. Aortitis: Giant cell arteritis, Takayasu arteritis etc.;

12. Patients with malignant tumor whose life expectancy is less than 1 year;

13. Intolerance to endotracheal intubation and general anesthesia;

14. Pregnant women.