Aortic DissectionNCT03347812
Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair
An observational study of Aortic Dissection and Aortic Arch Aneurysm, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Aortic Dissection, Aortic Arch Aneurysm, Ulcer
- What is being tested?
- Endovascular Aortic Repair and Total Arch Replacement
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 4 sitesChina
- Study dates
- 22 Nov 2017to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Not yet recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100000
Qian Zhou, 010-58115036
- Not yet recruiting
Chian-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000
Yong Cui, 010-84205147
- Recruiting
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, 100000
Enhua Cao, +86 010 68331867, caoeh62@163.com
- Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100000
Tao Xu, 010-88325911
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Dissection, Aortic Arch Aneurysm, Ulcer, Pseudoaneurysm
- Being tested
- Endovascular Aortic Repair, Total Arch Replacement
- Keywords
- Aortic Arch, Endovascular Treatment, Traditional Open Surgery, Chimney Technique, Fenestration Technique, Branched Stent-grafts Technique
- Medical subject headings
- Aortic Dissection, Aneurysm, Aortic Arch, Ulcer, Aneurysm, False
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Aortic RepairProcedure or surgery
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 ReplacementProcedure or surgery
A kind of open surgery is performed for the replacement of total aortic arch.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endovascular Aortic Repair | |
| 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. Receives: Procedure: Total Arch Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
No death within 30 days after surgery
Death from all causes would be included.
Measured: 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.
Measured: 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.
Measured: 12 month after surgery
Secondary outcomes (10)
Postoperative leakage
Leakage is divided into five types according to the eighth edition of Rutherford Vascular Surgery.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start22 Nov 2017
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, China-Japan Friendship Hospital, Beijing Hospital
- Responsible party
- Principal investigator, Chang Shu, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Chang Shu, Director, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347812
- Sponsor's protocol ID
- D171100002917004
- Status last verified
- Dec 2017
- First submitted
- 5 Nov 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Evaluation of Total Endovascular Aortic Arch Repair
- ClinicalTrials.gov ID
- NCT03347812
- Acronym / sponsor ID
- D171100002917004
- Conditions
- Aortic Dissection, Aortic Arch Aneurysm, Ulcer, Pseudoaneurysm
- Keywords
- Aortic Arch, Endovascular Treatment, Traditional Open Surgery, Chimney Technique, Fenestration Technique, Branched Stent-grafts Technique
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, China-Japan Friendship Hospital, Beijing Hospital
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Aortic Repair | – | Procedure: Endovascular Aortic RepairPatients 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. |
| Total Arch Replacement | – | Procedure: Total Arch ReplacementPatients with aortic arch lesions who only received traditional open surgery for total aortic arch replacement, would be assigned to this group. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Aortic RepairWithout 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. | Procedure or surgery | Endovascular Aortic Repair |
| Total Arch ReplacementA kind of open surgery is performed for the replacement of total aortic arch. | Procedure or surgery | Total Arch Replacement |
Primary outcome
No death within 30 days after surgery
Time frame: 1 month after surgery for treating aortic arch disease performed
Death from all causes would be included.
No adverse cardiovascular and cerebrovascular events within one year after surgery
Time frame: 12 month after surgery for treating aortic arch disease performed
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.
No reoperative intervention associated with aorta occurred within one year after surgery
Time frame: 12 month after surgery
Reoperative intervention associated with aorta means unintended open or endovascular treatment of the aortic disease, excluding non-aortic surgery.
10 secondary outcomes
Postoperative leakage
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
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
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
Time frame: 30 days after surgery for treating aortic arch disease performed.
Hypostatic pneumonia
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Shu, Director principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection and Aortic Arch Aneurysm, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingyao Luo, Physician (+86 17701022238, luomingyao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No death within 30 days after surgery (time frame: 1 month after surgery for treating aortic arch disease performed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2017.