Status:
UNKNOWN
EndovaScular Versus mediCaL mAnagement of Uncomplicated Type B Intramural heMatoma Trial (ESCLAIM)
Lead Sponsor:
Guangdong Provincial People's Hospital
Collaborating Sponsors:
First Affiliated Hospital of Xinjiang Medical University
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Intramural Hematoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 endovascul...
Detailed Description
Intervention group (TEVAR plus OMT): patients will undergo TEVAR besides strict control of blood pressure and heart rate and pain management as mentioned above. According to the preoperative imaging, ...
Eligibility Criteria
Inclusion
- 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
- Persistent or recurrent pain despite full medication,;
- Hemodynamic instability;
- Signs of rupture (periaortic hemorrhage);
- Depth of ULP \> 10 mm;
- Aortic diameter \> 55 mm;
- ULP around with calcification;
- Previous history of aortic-related procedures;
- Blunt thoracic aortic injury;
- Iatrogenic aortic injury;
- Inherited diseases: Turner syndrome, Marfan syndrome, Ehlers-Danlos syndrome, Loeys Dietz syndrome etc.;
- Aortitis: Giant cell arteritis, Takayasu arteritis etc.;
- Patients with malignant tumor whose life expectancy is less than 1 year;
- Intolerance to endotracheal intubation and general anesthesia;
- Pregnant women.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04808661
Start Date
March 1 2021
End Date
March 1 2024
Last Update
June 3 2021
Active Locations (1)
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1
#106 Dongchuan Second Road, Yuexiu District
Guangzhou, Guangdong, China, 510000