An observational study in Aortic Dissection, Aortic Arch Aneurysm and Ulcer, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Status unknown at 4 sites in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-27.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Observational
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 aorta, descending aorta and abdominal aorta are becoming more and more mature. However, due to the complexity of the aortic arch in anatomy, function and pathological changes, the optimal treatment strategy for diseases in the aortic arch has been controversial constantly.
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.
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 both withstand traditional total aortic arch replacement (TAR) and are suitable for complete thoracic endovascular aortic repair (cTEVAR) in terms of anatomical structure. According to the requirement of statistical analysis, more than 400 patients would be enrolled in the four centers (Fuwai Hospital, Peking University People's Hospital, China-Japan Friendship Hospital and Beijing Hospital) within 2 years. Combined the actual situation of the patients, subjects would be divided into TAR and cTEVAR groups. During the study, the investigators would collect the data including blood and biochemical indexes, complications, aortic CT examination, surgical procedure, and the follow-up information in discharge, one month after surgery, six months after surgery and twelve months after surgery.
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.
205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.
This study's planned enrollment of 400 is above the median of 230 across 115 observational studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 147 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients had aortic arch lesions, need surgery, and are hospitalized in these four hospitals (Fuwai Hospital, Beijing Hospital, China-Japan Friendship Hospital and Peking University People's Hospital) . These four hospitals are all located in Beijing, China.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Endovascular Aortic Repair
Patients with aortic arch lesions who only received traditional open surgery for total aortic arch replacement, would be assigned to this group.
Procedure: Total Arch Replacement
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.
A kind of open surgery is performed for the replacement of total aortic arch.
No death within 30 days after surgery
Death from all causes would be included.
Time frame: 1 month after surgery for treating aortic arch disease performed
No adverse cardiovascular and cerebrovascular events within one year after surgery
Cerebrovascular adverse events include global neurological deficit, focal neurological deficit and spinal neurological deficit. Cardiovascular adverse events include extensive myocardial ischemia, low cardiac output syndrome, malignant arrhythmia and massive pericardial effusion.
Time frame: 12 month after surgery for treating aortic arch disease performed
No reoperative intervention associated with aorta occurred within one year after surgery
Reoperative intervention associated with aorta means unintended open or endovascular treatment of the aortic disease, excluding non-aortic surgery.
Time frame: 12 month after surgery
Postoperative leakage
Leakage is divided into five types according to the eighth edition of Rutherford Vascular Surgery.
Time frame: When patient is discharged from hospital after surgery for treating aortic arch disease performed, 6 month and 12 month after surgery for treating aortic arch disease performed
Patency rate of aortic arch branches
The patency of aortic arch branches (anonymous artery, left carotid artery, left subclavian artery), and whether occlusion, stenosis, thrombosis occurring in branches.
Time frame: When patient is discharged from hospital after surgery for treating aortic arch disease performed, 6 month and 12 month after surgery for treating aortic arch disease performed
Device-related adverse events occurred
Device-related adverse events include stent unable deploy and / or relaying to surgery, the dissection, thrombus, hematoma, pseudoaneurysm or infection of the access artery, unexplained fever continued for more than month, device-induced aortic dissection rupture or tear, displacement, infection, fracture of stent-grafts.
Time frame: When patient is discharged from hospital after surgery for treating aortic arch disease performed, 1 month, 6 month and 12 month after surgery for treating aortic arch disease performed
Postoperative new pulmonary infections
New pulmonary infections occurred within 30 days after surgery.
Time frame: 30 days after surgery for treating aortic arch disease performed.
Hypostatic pneumonia
Long-term bed rest caused chronic congestion in the bottom of the lungs.
Time frame: When patient is discharged from hospital after surgery for treating aortic arch disease performed, 1 month, 6 month and 12 month after surgery for treating aortic arch disease performed
Lower extremity deep vein thrombosis
It refers to the coagulation of venous blood in deep veins of the lower extremities.
Time frame: When patient is discharged from hospital after surgery for treating aortic arch disease performed, 1 month, 6 month and 12 month after surgery for treating aortic arch disease performed
Pulmonary embolism
Endogenous or exogenous embolus clogged the main pulmonary artery or branch, causing pulmonary circulatory disorders.
Time frame: When patient is discharged from hospital after surgery for treating aortic arch disease performed, 1 month, 6 month and 12 month after surgery for treating aortic arch disease performed
Wound infection
Wounds occurred postoperative infection.
Time frame: When patient is discharged from hospital after surgery for treating aortic arch disease performed, 1 month, 6 month and 12 month after surgery for treating aortic arch disease performed
Liver dysfunction
Child-pugh's Grade of patient is B or C grade.
Time frame: When patient is discharged from hospital after surgery for treating aortic arch disease performed, 1 month, 6 month and 12 month after surgery for treating aortic arch disease performed
Renal dysfunction
Serum creatinine is more than 186umol/L.
Time frame: When patient is discharged from hospital after surgery for treating aortic arch disease performed, 1 month, 6 month and 12 month after surgery for treating aortic arch disease performed
Extremities blood pressure measurement
Blood pressure of left upper limb, right upper limb, left lower limb, right lower limb
Time frame: 3 days before the surgery for treating aortic arch disease performed, 5 days after surgery for treating aortic arch disease performed
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2017 (actual). Primary completion is estimated for Mar 2020, 28 months after the start.
Of 48 observational studies under Aortic Dissection, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 135. This study's planned 28 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences, Fuwai Hospital →