Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair
NCT ID: NCT03347812
Last Updated: 2017-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2017-11-22
2020-03-31
Brief Summary
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This research is a multi-center(four centers), prospective, controlled, large-scale (about 400 subjects) clinical study, using traditional thoracic surgery of aortic arch disease as a control to verify that new techniques for endovascular treatment is not inferior to traditional thoracic surgery in terms of efficiency and safety.
Further more, the investigators plan to explore the indications of the application of these new techniques, develop a better diagnosis and treatment program, reduce the risk of such surgical treatment and the incidence of complications, improve clinical efficacy and the overall quality of the disease.
Detailed Description
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The primary endpoint of this study is one-year treatment success, which means there are no death within 30 days after surgery, no adverse cardiovascular and no cerebrovascular events and no re-operative intervention associated with aorta occurred during the 1-year follow-up period. Secondary endpoints include the occurrence of postoperative leaks, occlusion, stenosis and thrombosis of aortic arch branches, the incidence of device-related adverse events, and the incidence of other serious complications. This study uses the primary endpoint as a measure of efficacy, and the secondary endpoint as a measure of safety for both treatment methods. The primary analysis of collected data would be based on intention-to-treat (ITT) principle, and all enrolled patients would be included in the final analysis.
The Cochran-Mantel-Haenszel (CMH) chi square analysis for adjusting center effects will be used for comparisons of major indicators, estimating differences in success rates and their 95% confidence intervals in two groups. If the lower limit of the 95% Confidence Interval (CI) of the difference in success rate between the test group and control group exceeds the pre-established non-inferiority cutoff, the endovascular treatment can be considered to be as effective as traditional open surgery. The significance level for all statistical tests is 5%, and the statistical analysis software is Statistics Analysis System (SAS) 9.3.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Endovascular Aortic Repair
Patients with aortic arch lesions who only received endovascular treatment, including chimney / fenestration / branch stent-grafts technique and combination of these techniques, would be assigned to this group.
Endovascular Aortic Repair
Without surgery to expose the lesion directly, minimal invasive treatment for the aortic arch lesion under the guidance of imaging equipment is performed through the blood vessel with a tiny wound of a few centimeters, in our research, including chimney, branch stent-grafts and fenestration techniques.
Total Arch Replacement
Patients with aortic arch lesions who only received traditional open surgery for total aortic arch replacement, would be assigned to this group.
Total Arch Replacement
A kind of open surgery is performed for the replacement of total aortic arch.
Interventions
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Endovascular Aortic Repair
Without surgery to expose the lesion directly, minimal invasive treatment for the aortic arch lesion under the guidance of imaging equipment is performed through the blood vessel with a tiny wound of a few centimeters, in our research, including chimney, branch stent-grafts and fenestration techniques.
Total Arch Replacement
A kind of open surgery is performed for the replacement of total aortic arch.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
40 Years
75 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Beijing Hospital
OTHER_GOV
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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Chang Shu
Director of Vascular Surgery Center
Principal Investigators
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Chang Shu, Director
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Chian-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Qian Zhou
Role: primary
Yong Cui
Role: primary
Enhua Cao
Role: primary
Tao Xu
Role: primary
Other Identifiers
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D171100002917004
Identifier Type: -
Identifier Source: org_study_id