Type B Aortic DissectionNCT07022145
Real-World Prospective Parallel Controlled Study on Endovascular Therapy for Improving Perfusion and Remodeling of TBAD
An observational study of Type B Aortic Dissection, run by Shanghai Zhongshan Hospital.
Trial summary
There are both common and individual characteristics in patients with type B aortic dissection. Currently, for all subtypes of acute type B dissection, proximal endovascular repair is mostly performed during the subacute phase, while the distal dissection of the descending aorta is often managed with a "watch and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type B Aortic Dissection
- What is being tested?
- Endovascular repair
- Type of treatment
- Surgery or procedure
- How many people
- 438 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to May 2030
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population: Patients with type B aortic dissection receiving real-world clinical diagnosis and treatment at each participating center. Definition of Acute Complicated Type B Aortic Dissection: Patients diagnosed with type B aortic dissection within 14 days of symptom onset who present with rupture/imminent rupture, associated ischemic syndromes (bowel, renal, or lower limb ischemia), radiologic progression of dissection or aortic dilation during hospitalization, uncontrolled hypertension, or refractory pain lasting more than 12 hours. Definition of Acute High-Risk Type B Aortic Dissection: Patients diagnosed with type B aortic dissection within 14 days of symptom onset who exhibit one or more of the following: total aortic diameter >40 mm, false lumen diameter >22 mm, primary entry tear >10 mm, entry tear located on the inner curvature, hemothorax, radiologic signs of ischemia (bowel, renal, or lower limb), or recurrent pain/symptoms.
Who may be able to join
- Male participants aged ≥18 years or non-pregnant female participants
- Diagnosed with acute complicated type B aortic dissection (defined as rupture/imminent rupture, associated ischemic syndromes [bowel, renal, or lower limb ischemia], radiologic progression of dissection or aortic dilation during hospitalization, uncontrolled hypertension, or refractory pain lasting over 12 hours), or high-risk type B dissection (defined as total aortic diameter >40 mm, false lumen diameter >22 mm, primary entry tear >10 mm, entry on the inner curvature, hemothorax, radiologic signs of ischemia [bowel, renal, or lower limb], or recurrent pain/symptoms).
- Patients deemed suitable for TEVAR or TEVAR combined with supra-aortic single-branch endovascular repair, as assessed by the investigator
- Patients who understand the purpose of the study, voluntarily agree to participate by signing informed consent, and are willing to comply with follow-up requirements
Who cannot join
- Subjects with hemodynamic instability or ruptured aortic dissection
- Subjects who, due to anatomical factors, are unsuitable for isolated TEVAR or TEVAR combined with supra-aortic single-branch reconstruction
- Subjects with connective tissue disorders, such as Marfan syndrome
- Subjects in poor general condition who cannot tolerate general anesthesia
- Subjects with known allergies to contrast agents or stent materials such as nitinol
- Subjects with a life expectancy of less than 12 months
Show all 10Show fewer
- Subjects with a history of myocardial infarction or unstable angina within the past 3 months
- Subjects with a history of TIA or cerebral infarction within the past 3 months
- Subjects with serum creatinine levels >2.5 times the upper limit of normal or currently on dialysis
- Subjects with severe comorbidities such as liver failure
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: A Real-World Multicenter, Prospective, Non-Randomized Parallel Controlled Study on the Optimal Endovascular Therapy for Improving Distal Perfusion and Remodeling of Acute Type B Aortic Dissection
There are both common and individual characteristics in patients with type B aortic dissection. Currently, for all subtypes of acute type B dissection, proximal endovascular repair is mostly performed during the subacute phase, while the distal dissection of the descending aorta is often managed with a "watch and wait" strategy. However, such a uniform approach carries potential risks, including imprecise indications, inappropriate timing, and uncertain prognosis. Our research team has previously established a comprehensive database and imaging repository of nearly 10,000 cases of type B dissection. Building upon existing subtypes-such as acute complicated, uncomplicated, penetrating atherosclerotic ulcer, and intramural hematoma-we have further explored refined classifications, including acute high-risk types and localized contrast enhancement of the aortic wall. For patients with different subtypes and at different stages of dissection-such as hyperacute, acute, or subacute-it is critical to develop individualized treatment strategies. These may include optimal medical therapy, isolated proximal endovascular repair, or combined proximal repair with distal bare stent implantation. Therefore, a large-scale clinical study is urgently needed to identify the optimal timing and approach for intervention based on refined classification schemes, and to establish personalized, stratified treatment strategies for different patient groups.
This project aims to conduct a real-world, prospective, multicenter, parallel-controlled study to compare outcomes between isolated proximal endovascular repair and combined proximal repair with distal bare stent implantation in patients with acute complicated or high-risk type B aortic dissection. The goal is to determine the most effective surgical approach for improving distal perfusion and promoting favorable aortic remodeling, thereby guiding treatment decision-making.
- Conditions
- Type B Aortic Dissection
- Being tested
- Endovascular repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular repairProcedure or surgery
Endovascular repair using proximal stent-graft or proximal stent-graft combined with distal stent for TBAD patients
| Study group | Role | What they receive |
|---|---|---|
| PSG | Type B aortic dissection patients treated with proximal stent-graft Receives: Procedure: Endovascular repair | |
| PSG+DBS | Type B aortic dissection patients treated with proximal stent-graft combined with distal bare stent Receives: Procedure: Endovascular repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day Postoperative Positive Remodeling Rate of the Descending Thoracic Aorta
(Number of subjects with positive remodeling of the descending thoracic aorta at the 30-day postoperative visit / Total number of subjects who completed the 30-day postoperative visit) × 100%
Measured: 30 days
12-month Postoperative Degree of Positive Remodeling of the Descending Thoracic Aorta
Positive aortic remodeling is defined as meeting at least one of the following criteria:
A reduction in the maximum diameter or volume of the false lumen, accompanied by either a decrease or an increase of less than 5 mm in the total aortic diameter or volume;
An increase in the maximum diameter or volume of the true lumen, accompanied by either a decrease or an increase of less than 5 mm in the total aortic diameter or volume;
A reduction in the maximum aortic diameter (along with changes in the diameters of both the true and false lumens).
Formula for calculating the degree of positive remodeling of the descending thoracic aorta at 12 months postoperatively:
(Maximum true lumen diameter of the descending thoracic aorta at 12 months post-op / Maximum total lumen diameter at 12 months post-op) - (Preoperative maximum true lumen diameter / Preoperative maximum total lumen diameter of the descending thoracic aorta)
Measured: 12 months
Secondary outcomes (7)
3-month Postoperative Positive Remodeling Rate of the Descending Thoracic Aorta
Measured: 3 months
Incidence of Distal Stent-Induced New Entry (d-SINE) During Follow-up Incidence of Distal Stent-Induced New Entry (d-SINE) During Follow-up Incidence of Distal Stent-Induced New Entry (d-SINE) During Follow-up
Measured: 5 years
Rate of Visceral Arterial Branch Lumen Loss During Follow-up
Measured: 5 years
Degree of Positive Remodeling of the Abdominal Aorta During Follow-up Degree of Positive Remodeling of the Abdominal Aorta During Follow-up Degree of Positive Remodeling of the Abdominal Aorta During Follow-up
Measured: 5 years
All-Cause Mortality Rate During Follow-up
Measured: 5 years
Aortic-related Mortality Rate During Follow-up
Measured: 5 years
Aortic-related Reintervention Rate During Follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type B Aortic DissectionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 438 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihui Dong, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022145
- Sponsor's protocol ID
- 2023ZD-TEVAR-DBS
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2025
- Last updated
- 15 Jun 2025
- 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Multicenter, Prospective, Non-Randomized Parallel Controlled Study on the Optimal Endovascular Therapy for Improving Distal Perfusion and Remodeling of Acute Type B Aortic Dissection
- ClinicalTrials.gov ID
- NCT07022145
- Acronym / sponsor ID
- 2023ZD-TEVAR-DBS
- Conditions
- Type B Aortic Dissection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 15 Jun 2025 (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.
There are both common and individual characteristics in patients with type B aortic dissection. Currently, for all subtypes of acute type B dissection, proximal endovascular repair is mostly performed during the subacute phase, while the distal dissection of the descending aorta is often managed with a "watch and wait" strategy. However, such a uniform approach carries potential risks, including imprecise indications, inappropriate timing, and uncertain prognosis. Our research team has previously established a comprehensive database and imaging repository of nearly 10,000 cases of type B dissection. Building upon existing subtypes-such as acute complicated, uncomplicated, penetrating atherosclerotic ulcer, and intramural hematoma-we have further explored refined classifications, including acute high-risk types and localized contrast enhancement of the aortic wall. For patients with different subtypes and at different stages of dissection-such as hyperacute, acute, or subacute-it is critical to develop individualized treatment strategies. These may include optimal medical therapy, isolated proximal endovascular repair, or combined proximal repair with distal bare stent implantation. Therefore, a large-scale clinical study is urgently needed to identify the optimal timing and approach for intervention based on refined classification schemes, and to establish personalized, stratified treatment strategies for different patient groups.
This project aims to conduct a real-world, prospective, multicenter, parallel-controlled study to compare outcomes between isolated proximal endovascular repair and combined proximal repair with distal bare stent implantation in patients with acute complicated or high-risk type B aortic dissection. The goal is to determine the most effective surgical approach for improving distal perfusion and promoting favorable aortic remodeling, thereby guiding treatment decision-making.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSG | – | Procedure: Endovascular repairType B aortic dissection patients treated with proximal stent-graft |
| PSG+DBS | – | Procedure: Endovascular repairType B aortic dissection patients treated with proximal stent-graft combined with distal bare stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population: Patients with type B aortic dissection receiving real-world clinical diagnosis and treatment at each participating center. Definition of Acute Complicated Type B Aortic Dissection: Patients diagnosed with type B aortic dissection within 14 days of symptom onset who present with rupture/imminent rupture, associated ischemic syndromes (bowel, renal, or lower limb ischemia), radiologic progression of dissection or aortic dilation during hospitalization, uncontrolled hypertension, or refractory pain lasting more than 12 hours. Definition of Acute High-Risk Type B Aortic Dissection: Patients diagnosed with type B aortic dissection within 14 days of symptom onset who exhibit one or more of the following: total aortic diameter >40 mm, false lumen diameter >22 mm, primary entry tear >10 mm, entry tear located on the inner curvature, hemothorax, radiologic signs of ischemia (bowel, renal, or lower limb), or recurrent pain/symptoms.
Key inclusion criteria (4 listed)
- Male participants aged ≥18 years or non-pregnant female participants
- Diagnosed with acute complicated type B aortic dissection (defined as rupture/imminent rupture, associated ischemic syndromes [bowel, renal, or lower limb ischemia], radiologic progression of dissection or aortic dilation during hospitalization, uncontrolled hypertension, or refractory pain lasting over 12 hours), or high-risk type B dissection (defined as total aortic diameter >40 mm, false lumen diameter >22 mm, primary entry tear >10 mm, entry on the inner curvature, hemothorax, radiologic signs of ischemia [bowel, renal, or lower limb], or recurrent pain/symptoms).
- Patients deemed suitable for TEVAR or TEVAR combined with supra-aortic single-branch endovascular repair, as assessed by the investigator
- Patients who understand the purpose of the study, voluntarily agree to participate by signing informed consent, and are willing to comply with follow-up requirements
Key exclusion criteria (10 listed)
- Subjects with hemodynamic instability or ruptured aortic dissection
- Subjects who, due to anatomical factors, are unsuitable for isolated TEVAR or TEVAR combined with supra-aortic single-branch reconstruction
- Subjects with connective tissue disorders, such as Marfan syndrome
- Subjects in poor general condition who cannot tolerate general anesthesia
- Subjects with known allergies to contrast agents or stent materials such as nitinol
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 repairEndovascular repair using proximal stent-graft or proximal stent-graft combined with distal stent for TBAD patients | Procedure or surgery | PSG, PSG+DBS |
Primary outcome
30-day Postoperative Positive Remodeling Rate of the Descending Thoracic Aorta
Time frame: 30 days
(Number of subjects with positive remodeling of the descending thoracic aorta at the 30-day postoperative visit / Total number of subjects who completed the 30-day postoperative visit) × 100%
12-month Postoperative Degree of Positive Remodeling of the Descending Thoracic Aorta
Time frame: 12 months
Positive aortic remodeling is defined as meeting at least one of the following criteria: A reduction in the maximum diameter or volume of the false lumen, accompanied by either a decrease or an increase of less than 5 mm in the total aortic diameter or volume; An increase in the maximum diameter or volume of the true lumen, accompanied by either a decrease or an increase of less than 5 mm in the total aortic diameter or volume; A reduction in the maximum aortic diameter (along with changes in the diameters of both the true and false lumens). Formula for calculating the degree of positive remodeling of the descending thoracic aorta at 12 months postoperatively: (Maximum true lumen diameter of the descending thoracic aorta at 12 months post-op / Maximum total lumen diameter at 12 months post-op) - (Preoperative maximum true lumen diameter / Preoperative maximum total lumen diameter of the descending thoracic aorta)
7 secondary outcomes
3-month Postoperative Positive Remodeling Rate of the Descending Thoracic Aorta
Time frame: 3 months
Incidence of Distal Stent-Induced New Entry (d-SINE) During Follow-up Incidence of Distal Stent-Induced New Entry (d-SINE) During Follow-up Incidence of Distal Stent-Induced New Entry (d-SINE) During Follow-up
Time frame: 5 years
Rate of Visceral Arterial Branch Lumen Loss During Follow-up
Time frame: 5 years
Degree of Positive Remodeling of the Abdominal Aorta During Follow-up Degree of Positive Remodeling of the Abdominal Aorta During Follow-up Degree of Positive Remodeling of the Abdominal Aorta During Follow-up
Time frame: 5 years
All-Cause Mortality Rate During Follow-up
Time frame: 5 years
Aortic-related Mortality Rate During Follow-up
Time frame: 5 years
Aortic-related Reintervention Rate During Follow-up
Time frame: 5 years
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 15 Jun 2025.
- 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 Type B Aortic Dissection, run by Shanghai Zhongshan Hospital.
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 15 Jun 2025. 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 Yuanqing Kan (+8613585939248, echok624@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day Postoperative Positive Remodeling Rate of the Descending Thoracic Aorta (time frame: 30 days). The study lists 2 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 15 Jun 2025.