Status:
UNKNOWN
Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborating Sponsors:
Peking University People's Hospital
China-Japan Friendship Hospital
Conditions:
Aortic Dissection
Aortic Arch Aneurysm
Eligibility:
All Genders
40-75 years
Brief Summary
Aortic disease is a kind of cardiovascular diseases with very high mortality rate and high risk of surgical treatment. At present, the surgical and endovascular treatment for diseases in the ascending...
Detailed Description
The subjects in this study are patients with aortic arch disease, after scientific assessment made by the team with wide experience in aortic open surgery and endovascular treatment, who are able to b...
Eligibility Criteria
Inclusion
- Patients have aortic arch lesions caused by atherosclerosis and hypertension, and are also suitable for both chimney/ fenestration / branch stent-grafts technique and total arch replacement surgery simultaneously.
- Lesions involve the aortic arch, at least one branch of the aortic arch to be revascularized.
- The type of lesion is dissection, aneurysm, pseudoaneurysm, or ulcer.
- Life expectancy is more than 1 year.
- Patients are able to understand the purpose of this trial, voluntarily attend and sign the informed consent form, and are willing to accept the specified follow-up at specific time point.
Exclusion
- Patients had a stroke or ST-segment elevation myocardial infarction within 30 days prior to surgery.
- Patients underwent major surgery (grade 3 or above) or interventional therapy within 30 days prior to surgery.
- Patients will undergo any major elective surgery (grade 3 or above) or interventional therapy within 30 days after surgery.
- Patients had a previous thoracic aortic surgery in the past.
- Patients had previous thoracic aortic endovascular treatment, and the last implants had an effect on this procedure or had intersections with implants would be used in this procedure.
- Patients need intervention in other vascular lesions (such as coronary arteries, lower extremity arteries, carotid arteries) in the same procedure, or have heart disease and postoperative medication regimens are affected.
- Patients have hepatic and renal insufficiency (serum creatinine\> 186umol / L, Child-Pugh grade B, grade C).
- Aortic arch lesions are not caused by atherosclerosis or hypertension, such as connective tissue disease, aortic genetic diseases, etc.
- Aortic arch lesions are caused by Infectious diseases.
- Patients had serious illnesses (eg, severe chronic obstructive pulmonary disease (COPD) , cancer, dementia, etc.), or the physical condition would affect patients' compliance in this study.
- Patients are currently participating in other studies, and the primary endpoint has not been reached.
Key Trial Info
Start Date :
November 22 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03347812
Start Date
November 22 2017
End Date
March 1 2020
Last Update
December 27 2017
Active Locations (4)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100000
2
Chian-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100000
3
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, China, 100000
4
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100000