EndovaScular Versus mediCaL mAnagement of Uncomplicated Type B Intramural heMatoma Trial (ESCLAIM)
Primary Purpose
Intramural Hematoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thoracic endovascular aortic repair plus optimal medical therapy
Optimal medical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Intramural Hematoma
Eligibility Criteria
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,;
- 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.
Sites / Locations
- #106 Dongchuan Second Road, Yuexiu DistrictRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Conservative group
Arm Description
Thoracic endovascular aortic repair plus optimal medical therapy
Optimal medical therapy
Outcomes
Primary Outcome Measures
Incidence of aortic-relative events
A composite of hematoma malabsorption, aorta rupture, development of aortic dissection, aortic dilatation (aortic diameter >55 mm) and ulcer-like projection >10 mm in depth.
Secondary Outcome Measures
Rate of all-cause mortality
All-cause mortality includes aortic-related and nonaortic-related mortality
Rate of aortic-related mortality
Aortic-related death was defined as death attributable to an aortic cause during the initial admission or follow-up
Incidence of re-intervention
TEVAR plus OMT: secondary intervention; OMT: conversion to intervention.
Full Information
NCT ID
NCT04808661
First Posted
March 18, 2021
Last Updated
June 2, 2021
Sponsor
Guangdong Provincial People's Hospital
Collaborators
First Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Guangzhou Medical University, Jiangmen Central Hospital, Shenzhen People's Hospital, Jieyang People's Hospital, Wuhan Hanyang Hospital, Henan Provincial Chest Hospital, Xinqiao Hospital of Chongqing
1. Study Identification
Unique Protocol Identification Number
NCT04808661
Brief Title
EndovaScular Versus mediCaL mAnagement of Uncomplicated Type B Intramural heMatoma Trial (ESCLAIM)
Official Title
Randomized Comparison of Strategies for Uncomplicated Type B Aortic Intramural Hematoma: EndovaScular Versus mediCaL mAnagement of Type B Intramural heMatoma Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
Collaborators
First Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Guangzhou Medical University, Jiangmen Central Hospital, Shenzhen People's Hospital, Jieyang People's Hospital, Wuhan Hanyang Hospital, Henan Provincial Chest Hospital, Xinqiao Hospital of Chongqing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
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, the potential risk location of the aortic dissection or rupture and the extent of lesion involvement are evaluated, and the appropriate anchoring zone is selected to ensure a sufficient anchorage area of more than 15 mm. If the distance between the potential accident site and the left subclavian artery (LSA) is less than 15 mm, LSA will be covered to obtain sufficient anchoring area. LSA revascularization will be performed by chimney technique or hybrid operation, depending on the choice of the surgeon. The left femoral artery is punctured or cut, the artery sheath is inserted, and the pigtail catheter is inserted into the ascending aorta along the sheath. Next, the aortic covered stent was implanted reverse through the femoral artery under the guidance of the wire. When the stent was released, rapid pacing or intravenous antihypertensive drugs was used to ensure that the blood pressure was lower than 90 mmHg. After stent implantation, re-angiography to confirm the stent location and blood flow, which will indicate whether the operation was successful or not. After all above, the patients will be observed in the hospital for at least 3 days. Controls of the blood pressure and heart rate and relief of the symptoms will meet the discharge criteria.
Conservative group: all patients are under strict control of their blood pressure and heart rate with the guidelines-recommend drugs during hospitalization, including β receptor antagonists with or without other types of antihypertensive drugs if patients can tolerate. The target blood pressure is that systolic blood pressure fluctuates between 100-120 mmHg in the acute and sub-acute phase and blood pressure <130/80 mmHg in the chronic phase. The target heart rate should be limited to 60 bpm in the acute and sub-acute phases. Additionally, pain-releasing drugs ought to be prescribed when needed. Discharge criteria include control of the blood pressure and heart rate and relief of the symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intramural Hematoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Thoracic endovascular aortic repair plus optimal medical therapy
Arm Title
Conservative group
Arm Type
Active Comparator
Arm Description
Optimal medical therapy
Intervention Type
Procedure
Intervention Name(s)
Thoracic endovascular aortic repair plus optimal medical therapy
Other Intervention Name(s)
TEVAR plus OMT
Intervention Description
Endovascular treatment (thoracic endovascular aortic repair) plus optimal medical therapy
Intervention Type
Drug
Intervention Name(s)
Optimal medical therapy
Other Intervention Name(s)
OMT
Intervention Description
Optimal medical therapy (strictly control of their blood pressure and heart rate)
Primary Outcome Measure Information:
Title
Incidence of aortic-relative events
Description
A composite of hematoma malabsorption, aorta rupture, development of aortic dissection, aortic dilatation (aortic diameter >55 mm) and ulcer-like projection >10 mm in depth.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Rate of all-cause mortality
Description
All-cause mortality includes aortic-related and nonaortic-related mortality
Time Frame
One-year
Title
Rate of aortic-related mortality
Description
Aortic-related death was defined as death attributable to an aortic cause during the initial admission or follow-up
Time Frame
One-year
Title
Incidence of re-intervention
Description
TEVAR plus OMT: secondary intervention; OMT: conversion to intervention.
Time Frame
One-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fan Yang, MD
Phone
13922783426
Email
715886618@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guokui Zhang, MM
Phone
13622266656
Email
772379801@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfang Luo, MD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
#106 Dongchuan Second Road, Yuexiu District
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan Yang, MD
Phone
13922783426
Email
715886618@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
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EndovaScular Versus mediCaL mAnagement of Uncomplicated Type B Intramural heMatoma Trial (ESCLAIM)
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