Aortic Dissection Type BEVADENCT07143071
EndoVascular Aortic Dissection Early vs Delayed
An observational study of Aortic Dissection Type B, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is a prospective, multicenter, non-inferior, parallel-controlled observational study. This study aims to compare clinical outcomes of endovascular treatment for acute high-risk type B aortic dissection in the acute phase versus the subacute phase. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection Type B
- What is being tested?
- Acute Phase and Subacute Phase
- Type of treatment
- Surgery or procedure
- How many people
- 4,068 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Jul 2030
- 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: Acute (2-14 days) high-risk type B aortic dissection (defined by one or more of the following: aortic maximum diameter >40 mm, primary tear on the lesser curvature, false lumen diameter >22 mm, entry tear >10 mm, aortic diameter growth >5 mm during hospitalization, imaging evidence of visceral malperfusion, haemorrhagic pleural effusion, need for readmission, or recurrent chest pain).
Who may be able to join
- Acute (2-14 days) high-risk type B aortic dissection.
- Completion of thoracoabdominal aortic CTA before enrollment.
- Ability to understand the study objectives and voluntarily participate, with signed informed consent from the patient or their legal representative.
- Willingness and ability to comply with follow-up visits and study protocols.
Who cannot join
- Acute complicated type B aortic dissection.
- Traumatic dissection or penetrating aortic ulcer.
- Connective tissue diseases (e.g., Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome).
- Pregnancy, women of childbearing potential, or breastfeeding.
- Uncontrolled active infection or active vasculitis.
- Unsuitable access vessels or infection at the access site.
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- Endovascular repair requiring ≥2 branch reconstructions.
- Prior aortic surgery (open or endovascular).
- Life expectancy <2 years.
- Myocardial infarction or cerebrovascular accident within 4 weeks before enrollment.
- Severe gastrointestinal bleeding, major surgery, myocardial infarction, or uncorrected coagulation dysfunction within 6 weeks before enrollment.
- Other conditions deemed by the investigator to compromise the patient's medical interests or unlikely adherence to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endovascular Treatment for Acute High-risk Type B Aortic Dissection in Acute VS Subacute Phase: a Prospective, Multicenter, Non-inferior, Parallel Controlled Trial
This is a prospective, multicenter, non-inferior, parallel-controlled observational study. This study aims to compare clinical outcomes of endovascular treatment for acute high-risk type B aortic dissection in the acute phase versus the subacute phase. No interventions will be imposed on the patients' standard treatment. Patients with acute high-risk type B aortic dissection will be grouped based on the actual timing of their treatment.
- Conditions
- Aortic Dissection Type B
- Being tested
- Acute Phase, Subacute Phase
- Keywords
- aortic dissection, endovascular therapy, timing of intervention
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute PhaseProcedure or surgery
Patients with acute high-risk type B aortic dissection received endovascular treatment in acute phase (2-14days)
Subacute PhaseProcedure or surgery
Patients with acute high-risk type B aortic dissection received endovascular treatment in subacute phase (≥14days)
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute high-risk type B aortic dissection | Acute (2-14 days) high-risk type B aortic dissection (defined by one or more of the following: aortic maximum diameter >40 mm, primary tear on the lesser curvature, false lumen diameter >22 mm, entry tear >10 mm, aortic diameter growth >5 mm during hospitalization, imaging evidence of visceral malperfusion, haemorrhagic pleural effusion, need for readmission, or recurrent chest pain). Receives: Procedure: Acute Phase; Procedure: Subacute Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality rate
paraplegia, stroke, new entry tear, renal/liver dysfunction, type I/II/R endoleak
Measured: 30 days following the operation
30-day complication rate
access site complications
Measured: 30 days following the operation
Secondary outcomes (4)
Adverse events
rupture, stent-induced new entry, ischemia (renal/limb/intestinal/spinal), endoleak, dissection aneurysm, stroke, venous thrombosis, all-cause death.
Measured: 12 months following the operation
aortic remodeling
aortic diameter growth > 5 mm in 12 months; dissection aneurysm
Measured: 12 months following the operation
5-year all-cause mortality rate
long-term outcome
Measured: 5 years following the operation
5-year complication rate
long-term outcome
Measured: 5 years following the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Jul 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Dissection Type BStudies 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
- 4,068 participants (estimated)
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
- NCT07143071
- Sponsor's protocol ID
- B2024-370(2)R
- Other IDs
- 2023ZD0504300
- Acronym
- EVADE
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 27 Aug 2025
- 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment for Acute High-risk Type B Aortic Dissection in Acute VS Subacute Phase: a Prospective, Multicenter, Non-inferior, Parallel Controlled Trial
- ClinicalTrials.gov ID
- NCT07143071
- Acronym / sponsor ID
- EVADE / B2024-370(2)R
- Conditions
- Aortic Dissection Type B
- Keywords
- aortic dissection, endovascular therapy, timing of intervention
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,068 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 27 Aug 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.
This is a prospective, multicenter, non-inferior, parallel-controlled observational study. This study aims to compare clinical outcomes of endovascular treatment for acute high-risk type B aortic dissection in the acute phase versus the subacute phase. No interventions will be imposed on the patients' standard treatment. Patients with acute high-risk type B aortic dissection will be grouped based on the actual timing of their treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute high-risk type B aortic dissection | – | Procedure: Acute Phase, Procedure: Subacute PhaseAcute (2-14 days) high-risk type B aortic dissection (defined by one or more of the following: aortic maximum diameter >40 mm, primary tear on the lesser curvature, false lumen diameter >22 mm, entry tear >10 mm, aortic diameter growth >5 mm during hospitalization, imaging evidence of visceral malperfusion, haemorrhagic pleural effusion, need for readmission, or recurrent chest pain). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute (2-14 days) high-risk type B aortic dissection (defined by one or more of the following: aortic maximum diameter >40 mm, primary tear on the lesser curvature, false lumen diameter >22 mm, entry tear >10 mm, aortic diameter growth >5 mm during hospitalization, imaging evidence of visceral malperfusion, haemorrhagic pleural effusion, need for readmission, or recurrent chest pain).
Key inclusion criteria (4 listed)
- Acute (2-14 days) high-risk type B aortic dissection.
- Completion of thoracoabdominal aortic CTA before enrollment.
- Ability to understand the study objectives and voluntarily participate, with signed informed consent from the patient or their legal representative.
- Willingness and ability to comply with follow-up visits and study protocols.
Key exclusion criteria (12 listed)
- Acute complicated type B aortic dissection.
- Traumatic dissection or penetrating aortic ulcer.
- Connective tissue diseases (e.g., Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome).
- Pregnancy, women of childbearing potential, or breastfeeding.
- Uncontrolled active infection or active vasculitis.
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 |
|---|---|---|
| Acute PhasePatients with acute high-risk type B aortic dissection received endovascular treatment in acute phase (2-14days) | Procedure or surgery | Patients with acute high-risk type B aortic dissection |
| Subacute PhasePatients with acute high-risk type B aortic dissection received endovascular treatment in subacute phase (≥14days) | Procedure or surgery | Patients with acute high-risk type B aortic dissection |
Primary outcome
30-day all-cause mortality rate
Time frame: 30 days following the operation
paraplegia, stroke, new entry tear, renal/liver dysfunction, type I/II/R endoleak
30-day complication rate
Time frame: 30 days following the operation
access site complications
4 secondary outcomes
Adverse events
Time frame: 12 months following the operation
aortic remodeling
Time frame: 12 months following the operation
5-year all-cause mortality rate
Time frame: 5 years following the operation
5-year complication rate
Time frame: 5 years following the operation
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 27 Aug 2025.
- Related InfoLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Type B, run by Shanghai Zhongshan Hospital at 1 site 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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality rate (time frame: 30 days following the operation). 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 27 Aug 2025.