Type B Aortic DissectionNCT06740565
Conventional TEVAR Versus FABULOUS RCT
A study testing thoracic endovascular aortic repair in people with Type B Aortic Dissection, run by Shanghai Zhongshan Hospital.
Trial summary
For High-risk Type B aortic dissections, a multicenter, prospective, randomized controlled study is conducted to compare the clinical outcomes of conventional proximal endovascular repair (TEVAR) alone versus the Fabulous system which includes a proximal stent graft with a distal bare metal stent implanted. 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?
- thoracic endovascular aortic repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Feb 2029
- Phase
- Interventional
- 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
Who may be able to join
- Males aged 18 years or older, or non-pregnant females
- Diagnosed with high-risk Type B aortic dissection with a narrow true lumen (defined as the minimum true lumen diameter being less than 30% of the total vessel diameter) and/or poor radiographic or clinical visceral perfusion (including abnormal blood supply to the liver, kidneys, mesentery, or lower limb ischemia)
- Deemed suitable for endovascular treatment according to the investigator's judgment
- Able to understand the purpose of the trial, willing to participate voluntarily and sign the informed consent form, and committed to follow-up visits.
Who cannot join
- • Subjects with hemodynamic instability or ruptured aortic dissection
- Subjects who, due to various anatomical factors, are unable to undergo TEVAR alone
- Subjects with connective tissue diseases, such as Marfan syndrome
- Subjects in poor general condition, unable to tolerate general anesthesia
- Subjects allergic to contrast agents, nitinol stent materials, or other stent components
- 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 creatinine levels exceeding 2.5 times the upper normal limit or those currently on dialysis
- Subjects with severe conditions 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 Multicenter, Prospective, Randomized Control Study on the Optimal Intervention Approach for High-risk Type B Aortic Dissection
For High-risk Type B aortic dissections, a multicenter, prospective, randomized controlled study is conducted to compare the clinical outcomes of conventional proximal endovascular repair (TEVAR) alone versus the Fabulous system which includes a proximal stent graft with a distal bare metal stent implanted. The study aims to determine the optimal intervention method for such population.
Read the detailed description
Aortic dissection is characterized by its sudden onset, rapid progression, and life-threatening nature, with a natural mortality rate of 25% within 24 hours and 50% within 48 hours. As China's socioeconomic development accelerates and the population continues to age, the incidence of aortic dissection has been rising year by year. According to the China Cardiovascular Health and Disease Report 2022, cardiovascular diseases are now the leading cause of death among urban and rural residents in China. It is estimated that 245 million people in China suffer from hypertension, a major risk factor for aortic dissection. The Sino-RAD study on aortic dissection indicates that, compared to Western countries, China exhibits a "high incidence, early onset" trend, which is related to poor hypertension control. The average age of Chinese aortic dissection patients is 51.8 years, about 10 years younger than in Western countries, which significantly affects life expectancy and imposes a heavy economic burden on healthcare.
Type B aortic dissection refers to dissections originating from the left subclavian artery and beyond. Since 1999, when thoracic endovascular aortic repair (TEVAR) was first introduced internationally, there has been a revolutionary shift in the surgical treatment of B-type aortic dissection, transitioning from highly invasive open surgeries to minimally invasive endovascular treatments. This shift has greatly reduced perioperative mortality and complications. China's treatment of Type B aortic dissection has kept pace with international advancements. Data from the National Center for Cardiovascular Diseases Quality Control shows that from 2017 to 2022, the number of TEVAR surgeries in China increased from 13,709 per year to 24,076 per year, a growth of 75.6%. The number of hospitals performing TEVAR surgeries also increased from 627 to 1,050. However, with the increase in cases, clinical challenges have also emerged.
Type B aortic dissection patients exhibit both common and individual characteristics. Currently, for acute Type B dissections, regardless of subtype, most patients undergo proximal endovascular repair during the subacute phase, while a "watch and wait" strategy is adopted for dissections distal to the descending aorta. This single treatment approach carries potential risks, including inappropriate indications, mistimed interventions, and uncertain prognoses.
Our team has already established a database and imaging library with nearly ten thousand cases. Building on the study of acute complex, non-complex, penetrating ulcers, and intramural hematomas, we are delving deeper into acute high-risk subtypes and localized contrast enhancement of the aortic wall for more refined classifications. For patients with different classifications and at various stages of dissection, such as hyperacute, acute, and subacute phases, it is critical to develop individualized treatment strategies. These strategies may include optimal medical treatment, proximal endovascular repair alone, or a combination of proximal repair and distal petticoat techniques.
Therefore, large-scale clinical research is urgently needed to identify the best intervention timing and methods, based on refined classifications, to establish personalized, stratified diagnosis and treatment strategies for different patients.
- Conditions
- Type B Aortic Dissection
- Being tested
- thoracic endovascular aortic repair
- Keywords
- endovascular repair, distal bare stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic endovascular aortic repairProcedure or surgery
stent-graft implanted to seal the proximal entry tear of type B aortic dissection
| Study group | Role | What they receive |
|---|---|---|
| c-TEVAR | Active comparator | conventional thoracic endovascular aortic repair Receives: Procedure: thoracic endovascular aortic repair |
| Fabulous | Experimental | proximal stent graft combined with distal bare stent Receives: Procedure: thoracic endovascular aortic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-Month Positive Aortic Remodeling Rate
Definition of Positive Aortic Remodeling (meeting at least one of the following criteria). Reduction in the maximum diameter or volume of the false lumen with total aortic diameter or volume growth of less than 5mm or reduction. Increase in the maximum diameter or volume of the true lumen with total aortic diameter or volume growth of less than 5mm or reduction. Reduction in the maximum aortic diameter (with corresponding changes in both true and false lumen diameters).
Measured: 12-month postoperative
Secondary outcomes (1)
30-day Composite Major Adverse Events (MAE) Rate
The incidence of composite major adverse events include cardiac complications, pulmonary complications, renal failure, cerebrovascular complications, limb ischemia, bowel ischemia and spinal cord injury
Measured: 30-day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2029 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lixin Wang, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740565
- Sponsor's protocol ID
- TBAD202412
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Control Study on the Optimal Intervention Approach for High-risk Type B Aortic Dissection
- ClinicalTrials.gov ID
- NCT06740565
- Acronym / sponsor ID
- TBAD202412
- Conditions
- Type B Aortic Dissection
- Keywords
- endovascular repair, distal bare stent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 18 Dec 2024 (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.
For High-risk Type B aortic dissections, a multicenter, prospective, randomized controlled study is conducted to compare the clinical outcomes of conventional proximal endovascular repair (TEVAR) alone versus the Fabulous system which includes a proximal stent graft with a distal bare metal stent implanted. The study aims to determine the optimal intervention method for such population.
Detailed description
Aortic dissection is characterized by its sudden onset, rapid progression, and life-threatening nature, with a natural mortality rate of 25% within 24 hours and 50% within 48 hours. As China's socioeconomic development accelerates and the population continues to age, the incidence of aortic dissection has been rising year by year. According to the China Cardiovascular Health and Disease Report 2022, cardiovascular diseases are now the leading cause of death among urban and rural residents in China. It is estimated that 245 million people in China suffer from hypertension, a major risk factor for aortic dissection. The Sino-RAD study on aortic dissection indicates that, compared to Western countries, China exhibits a "high incidence, early onset" trend, which is related to poor hypertension control. The average age of Chinese aortic dissection patients is 51.8 years, about 10 years younger than in Western countries, which significantly affects life expectancy and imposes a heavy economic burden on healthcare.
Type B aortic dissection refers to dissections originating from the left subclavian artery and beyond. Since 1999, when thoracic endovascular aortic repair (TEVAR) was first introduced internationally, there has been a revolutionary shift in the surgical treatment of B-type aortic dissection, transitioning from highly invasive open surgeries to minimally invasive endovascular treatments. This shift has greatly reduced perioperative mortality and complications. China's treatment of Type B aortic dissection has kept pace with international advancements. Data from the National Center for Cardiovascular Diseases Quality Control shows that from 2017 to 2022, the number of TEVAR surgeries in China increased from 13,709 per year to 24,076 per year, a growth of 75.6%. The number of hospitals performing TEVAR surgeries also increased from 627 to 1,050. However, with the increase in cases, clinical challenges have also emerged.
Type B aortic dissection patients exhibit both common and individual characteristics. Currently, for acute Type B dissections, regardless of subtype, most patients undergo proximal endovascular repair during the subacute phase, while a "watch and wait" strategy is adopted for dissections distal to the descending aorta. This single treatment approach carries potential risks, including inappropriate indications, mistimed interventions, and uncertain prognoses.
Our team has already established a database and imaging library with nearly ten thousand cases. Building on the study of acute complex, non-complex, penetrating ulcers, and intramural hematomas, we are delving deeper into acute high-risk subtypes and localized contrast enhancement of the aortic wall for more refined classifications. For patients with different classifications and at various stages of dissection, such as hyperacute, acute, and subacute phases, it is critical to develop individualized treatment strategies. These strategies may include optimal medical treatment, proximal endovascular repair alone, or a combination of proximal repair and distal petticoat techniques.
Therefore, large-scale clinical research is urgently needed to identify the best intervention timing and methods, based on refined classifications, to establish personalized, stratified diagnosis and treatment strategies for different patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| c-TEVAR | Active comparator | Procedure: thoracic endovascular aortic repairconventional thoracic endovascular aortic repair |
| Fabulous | Experimental | Procedure: thoracic endovascular aortic repairproximal 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
Key inclusion criteria (4 listed)
- Males aged 18 years or older, or non-pregnant females
Key exclusion criteria (10 listed)
- • Subjects with hemodynamic instability or ruptured aortic dissection
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 |
|---|---|---|
| thoracic endovascular aortic repairstent-graft implanted to seal the proximal entry tear of type B aortic dissection | Procedure or surgery | Fabulous, c-TEVAR |
Primary outcome
12-Month Positive Aortic Remodeling Rate
Time frame: 12-month postoperative
Definition of Positive Aortic Remodeling (meeting at least one of the following criteria). Reduction in the maximum diameter or volume of the false lumen with total aortic diameter or volume growth of less than 5mm or reduction. Increase in the maximum diameter or volume of the true lumen with total aortic diameter or volume growth of less than 5mm or reduction. Reduction in the maximum aortic diameter (with corresponding changes in both true and false lumen diameters).
1 secondary outcome
30-day Composite Major Adverse Events (MAE) Rate
Time frame: 30-day postoperative
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 18 Dec 2024.
- Individual participant dataSharing planned: Yes
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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?
A study testing thoracic endovascular aortic repair in people with 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 18 Dec 2024. 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, MD (0086-13585939248, echok624@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-Month Positive Aortic Remodeling Rate (time frame: 12-month postoperative). 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 18 Dec 2024.