Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair

Clinical Study on Evaluation of Total Endovascular Aortic Arch Repair

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.

Study Overview

• Status: Unknown
• Conditions: Ulcer; Aortic Dissection; Aortic Arch Aneurysm; Pseudoaneurysm
• Intervention / Treatment: Procedure: Endovascular Aortic Repair; Procedure: Total Arch Replacement

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Not yet recruiting
      • Beijing Hospital
      • Contact: Qian Zhou; Phone Number: 010-58115036
    • Beijing, Beijing, China, 100000
      • Not yet recruiting
      • Chian-Japan Friendship Hospital
      • Contact: Yong Cui; Phone Number: 010-84205147
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Chinese Academy of Medical Sciences, Fuwai Hospital
      • Contact: Enhua Cao; Phone Number: +86 010 68331867; Email: caoeh62@163.com
    • Beijing, Beijing, China, 100000
      • Not yet recruiting
      • Peking University People's Hospital
      • Contact: Tao Xu; Phone Number: 010-88325911

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: 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.	Procedure: Total Arch Replacement; A kind of open surgery is performed for the replacement of total aortic arch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
No death within 30 days after surgery	Death from all causes would be included.	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.	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.	12 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative leakage	Leakage is divided into five types according to the eighth edition of Rutherford Vascular Surgery.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extremities blood pressure measurement	Blood pressure of left upper limb, right upper limb, left lower limb, right lower limb	3 days before the surgery for treating aortic arch disease performed, 5 days after surgery for treating aortic arch disease performed

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Collaborators: Peking University People's Hospital; Beijing Hospital; China-Japan Friendship Hospital
• Investigators: Principal Investigator: Chang Shu, Director, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: November 5, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 23, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Endovascular Treatment; Aortic Arch; Traditional Open Surgery; Chimney Technique; Fenestration Technique; Branched Stent-grafts Technique
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting; Aneurysm, False
• Other Study ID Numbers: D171100002917004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No