Clinical trial NCT03347812: Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair
Official title: Clinical Study on Evaluation of Total Endovascular Aortic Arch Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Aortic Arch Aneurysm
Ulcer
Pseudoaneurysm
Keywords: Aortic Arch
Endovascular Treatment
Traditional Open Surgery
Chimney Technique
Fenestration Technique
Branched Stent-grafts Technique
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: China-Japan Friendship Hospital
name: Beijing Hospital
First posted: 2017-11-20
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: No death within 30 days after surgery
timeFrame: 1 month after surgery for treating aortic arch disease performed
measure: No adverse cardiovascular and cerebrovascular events within one year after surgery
timeFrame: 12 month after surgery for treating aortic arch disease performed
measure: No reoperative intervention associated with aorta occurred within one year after surgery
timeFrame: 12 month after surgery
Secondary outcomes:
measure: Postoperative leakage
timeFrame: 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
measure: Patency rate of aortic arch branches
timeFrame: 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
measure: Device-related adverse events occurred
timeFrame: 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
measure: Postoperative new pulmonary infections
timeFrame: 30 days after surgery for treating aortic arch disease performed.
measure: Hypostatic pneumonia
timeFrame: 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
measure: Lower extremity deep vein thrombosis
timeFrame: 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
measure: Pulmonary embolism
timeFrame: 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
measure: Wound infection
timeFrame: 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
measure: Liver dysfunction
timeFrame: 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
measure: Renal dysfunction
timeFrame: 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
Other outcomes:
measure: Extremities blood pressure measurement
timeFrame: 3 days before the surgery for treating aortic arch disease performed, 5 days after surgery for treating aortic arch disease performed
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Chian-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences, Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Chang Shu, Director
role: PRINCIPAL_INVESTIGATOR
References: