Endovascular SurgeryNCT07745309
Type B Aortic Dissection Quality Control Platform
An observational study of Endovascular Surgery and Medical Quality, run by Chang Shu.
Trial summary
This study aims to establish a multicenter, prospective, observational registry database for type B aortic dissection based on approximately 60 regional sentinel hospitals across China. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endovascular Surgery, Medical Quality, Prognostic Early Warning
- What is being tested?
- Endo vascular repair
- Type of treatment
- Surgery or procedure
- How many people
- 2,375 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Aug 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients without any exclusion criteria who received treatment for Stanford type B aortic dissection at each participating center
Who may be able to join
- Aged between 18 and 80 years (inclusive);
- Definite diagnosis of Stanford type B aortic dissection confirmed by three-dimensional CTA reconstruction;
- Underwent TEVAR, including standalone TEVAR and hybrid procedures (only non-thoracotomy hybrid procedures);
- Patients and their families signed informed consent and agreed to complete the 2-year full follow-up.
Who cannot join
- Presence of severe comorbidities or other diseases (e.g., severe chronic obstructive pulmonary disease, malignant tumors, dementia) or any physical condition that may affect patient compliance with this study;
- A previous history of thoracic aortic surgery (including TEVAR, hybrid surgery, and open surgery);
- Congenital aortic malformations;
- Requiring concurrent intervention for cardiac or aortic sinus root lesions, or cardiac diseases that would alter the postoperative medication regimen;
- Pregnant or breastfeeding women;
- Complicated with Stanford type A intramural hematoma, supra-aortic vessel occlusion, or refusal of relevant repair;
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- A history of stroke or acute myocardial infarction within 30 days prior to surgery;
- Receipt of any major surgical or interventional procedures within 30 days prior to surgery;
- Scheduled to undergo any major elective surgical or interventional procedures within 30 days after index surgery;
- Participation in other ongoing drug or device trials with unmet primary study endpoints.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Construction of Type B Aortic Dissection Quality Control Platform and Risk Prediction Mechanism
This study aims to establish a multicenter, prospective, observational registry database for type B aortic dissection based on approximately 60 regional sentinel hospitals across China. It develops a digital intelligent management system, formulates quality control indicators and data collection standards for type B aortic dissection, and optimizes the data quality control and evaluation system to realize comprehensive evaluation covering the entire diagnosis and treatment process and long-term prognosis. Artificial intelligence algorithms are adopted to construct a risk prediction model for adverse events, and auxiliary decision-making software is developed to identify potential risks of adverse events in a timely manner and establish an early warning system, ultimately reducing the in-hospital complication and mortality rates.
Relying on the National Quality Control Platform for Peripheral Vascular Intervention, this study further builds a national quality control platform for type B aortic dissection covering more than 5,000 hospitals nationwide by establishing a three-level quality control system. By integrating health administrative data, quality control data, electronic medical record data and clinical research data, a high-quality, multi-dimensional national quality control platform is constructed to support the sustainable development of quality control work. In addition, a clinical research collaboration network will be established to conduct in-depth evaluation of the national diagnosis and treatment patterns and outcomes of type B aortic dissection. Regular national training and assessment programs will be organized to improve the overall diagnosis and treatment capacity of medical institutions at all levels and reduce regional and institutional disparities in the quality of clinical care for the disease.
- Conditions
- Endovascular Surgery, Medical Quality, Prognostic Early Warning, Stanford Type B Aortic Dissection
- Being tested
- Endo vascular repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo vascular repairProcedure or surgery
This is an observational study, and the intervention is the routine and standard care for patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major adverse events
Major adverse events includes all-cause death and complications (endoleak, stent-graft induced new entry tear (SINE), aortic rupture, retrograde type A aortic dissection, aorta-related re-intervention, myocardial infarction, stroke, paraplegia, renal insufficiency, and dialysis requirement)
Measured: From surgery completion to 30 days after surgery completion
Secondary outcomes (7)
Number of participants with adverse events
Participants with aorta-related re-intervention or all-cause death
Measured: From surgery completion to 6, 12 and 24 months after surgery completion
The change of distal true lumen diameter (unit: mm)
The change in distal true lumen (aorta below the stent graft) diameter before and after surgery
Measured: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
The change of distal false lumen diameter (unit: mm)
The change in distal false lumen (aorta below the stent graft) diameter before and after surgery
Measured: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
The number of false lumen thrombosis
The number of participants with false lumen thrombosis including complete thrombosis or partial thrombosis
Measured: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
The maximum aortic diameter at the dissected thoracic aortic segment
Maximum diameter of the thoracic segment involved by aortic dissection (the primary lesion site with the most severe aortic damage)
Measured: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
The maximum aortic diameter at the diaphragmatic level (unit: mm)
Measured: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
Maximum diameter of the abdominal aortic segment affected by dissection (unit: mm)
Measured: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular SurgeryStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 2,375 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Chang Shu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Chang Shu, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745309
- Sponsor's protocol ID
- FW2024-2503
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Type B Aortic Dissection Quality Control Platform and Risk Prediction Mechanism
- ClinicalTrials.gov ID
- NCT07745309
- Acronym / sponsor ID
- FW2024-2503
- Conditions
- Endovascular Surgery, Medical Quality, Prognostic Early Warning, Stanford Type B Aortic Dissection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,375 participants (estimated)
- Lead sponsor
- Chang ShuOther government
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 4 Aug 2026 (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.
This study aims to establish a multicenter, prospective, observational registry database for type B aortic dissection based on approximately 60 regional sentinel hospitals across China. It develops a digital intelligent management system, formulates quality control indicators and data collection standards for type B aortic dissection, and optimizes the data quality control and evaluation system to realize comprehensive evaluation covering the entire diagnosis and treatment process and long-term prognosis. Artificial intelligence algorithms are adopted to construct a risk prediction model for adverse events, and auxiliary decision-making software is developed to identify potential risks of adverse events in a timely manner and establish an early warning system, ultimately reducing the in-hospital complication and mortality rates.
Relying on the National Quality Control Platform for Peripheral Vascular Intervention, this study further builds a national quality control platform for type B aortic dissection covering more than 5,000 hospitals nationwide by establishing a three-level quality control system. By integrating health administrative data, quality control data, electronic medical record data and clinical research data, a high-quality, multi-dimensional national quality control platform is constructed to support the sustainable development of quality control work. In addition, a clinical research collaboration network will be established to conduct in-depth evaluation of the national diagnosis and treatment patterns and outcomes of type B aortic dissection. Regular national training and assessment programs will be organized to improve the overall diagnosis and treatment capacity of medical institutions at all levels and reduce regional and institutional disparities in the quality of clinical care for the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients without any exclusion criteria who received treatment for Stanford type B aortic dissection at each participating center
Key inclusion criteria (4 listed)
- Aged between 18 and 80 years (inclusive);
- Definite diagnosis of Stanford type B aortic dissection confirmed by three-dimensional CTA reconstruction;
- Underwent TEVAR, including standalone TEVAR and hybrid procedures (only non-thoracotomy hybrid procedures);
- Patients and their families signed informed consent and agreed to complete the 2-year full follow-up.
Key exclusion criteria (10 listed)
- Presence of severe comorbidities or other diseases (e.g., severe chronic obstructive pulmonary disease, malignant tumors, dementia) or any physical condition that may affect patient compliance with this study;
- A previous history of thoracic aortic surgery (including TEVAR, hybrid surgery, and open surgery);
- Congenital aortic malformations;
- Requiring concurrent intervention for cardiac or aortic sinus root lesions, or cardiac diseases that would alter the postoperative medication regimen;
- Pregnant or breastfeeding women;
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 |
|---|---|---|
| Endo vascular repairThis is an observational study, and the intervention is the routine and standard care for patients. | Procedure or surgery | – |
Primary outcome
Number of major adverse events
Time frame: From surgery completion to 30 days after surgery completion
Major adverse events includes all-cause death and complications (endoleak, stent-graft induced new entry tear (SINE), aortic rupture, retrograde type A aortic dissection, aorta-related re-intervention, myocardial infarction, stroke, paraplegia, renal insufficiency, and dialysis requirement)
7 secondary outcomes
Number of participants with adverse events
Time frame: From surgery completion to 6, 12 and 24 months after surgery completion
The change of distal true lumen diameter (unit: mm)
Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
The change of distal false lumen diameter (unit: mm)
Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
The number of false lumen thrombosis
Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
The maximum aortic diameter at the dissected thoracic aortic segment
Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
The maximum aortic diameter at the diaphragmatic level (unit: mm)
Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
Maximum diameter of the abdominal aortic segment affected by dissection (unit: mm)
Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Endovascular Surgery and Medical Quality, run by Chang Shu.
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wu Ziting (01060866636, wuziting1022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of major adverse events (time frame: From surgery completion to 30 days after surgery completion). 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 4 Aug 2026.