EndovaScular Versus mediCaL mAnagement of Uncomplicated Type B Intramural heMatoma Trial (ESCLAIM) (NCT04808661) | Clinical Trial Compass
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EndovaScular Versus mediCaL mAnagement of Uncomplicated Type B Intramural heMatoma Trial (ESCLAIM)
China154 participantsStarted 2021-03-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \>18 years;
✓. Be confirmed as Stanford type B IMH by aorta computed tomography;
✓. From onset to first clinical attach \<90 days;
✓. The subject or legal guardian understands the nature of the study and agrees to its;
✓. provisions on a written informed consent form;
✓. Availability for the appropriate follow-up visits during the follow-up period;
✓. Capability to follow all study requirements.
Exclusion criteria
✕. Persistent or recurrent pain despite full medication,;