Aortic DissectionNCT05883592
A Real-World Study on Distal Aortic Remodeling for Stanford Type B Aortic Dissection With Fabulous Thoracic Aortic Stent System
An observational study of Aortic Dissection, run by Hangzhou Endonom Medtech Co., Ltd. at 2 sites in China.
Trial summary
To evaluate aortic remodeling of Fabulous thoracic aortic stent system in the treatment of acute and subacute Stanford type B aortic dissection (the changes of aortic diameter, cross-sectional area,and volume of true lumen, false lumen and total aorta in different aoritc levels, and false lumen thrombosis in different… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Fabulous Thoracic Aortic Stent System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- May 2023to May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Stanford type B aortic dissection are treated with Fabulous Thoracic Aortic Stent System in the real world.
Who may be able to join
- ≥18 years old, regardless of gender;
- Fabulous thoracic aortic stent System is suitable for the treatment of acute or subacute Stanford type B dissection, and the lesions meet one of the following criteria:
- It is necessary to treat distal lesions due to the presence of distal tears;
- The dissection involved a wide range, and there was collapse of the distal true cavity;
- Dissection combined with poor perfusion of distal branch vessels.
- With appropriate arterial access and suitable for endovascular aortic repair;
- Subjects could understand the purpose of the trial, volunteered to participate in the study, signed the informed consent form by themselves or their legal representatives, and were willing to complete the follow-up as required by the protocol.
Who cannot join
- Patients have participated in clinical trials of other drugs or medical devices related to target lesion treatment or have participated in clinical trials of other drugs or medical devices and have not reached the primary endpoint;
- Patients were unable or unwilling to participate in the study;
- Patients were judged by the investigator to be ineligible for participation in the trial.
Trial locations and contacts
2 sites in 1 country.
Xi Guo contact
China2 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
Xi Guo
Beijing Friendship Hospital, Capital Medical University
Beijing
About this study
To evaluate aortic remodeling of Fabulous thoracic aortic stent system in the treatment of acute and subacute Stanford type B aortic dissection (the changes of aortic diameter, cross-sectional area,and volume of true lumen, false lumen and total aorta in different aoritc levels, and false lumen thrombosis in different aoritc levels), and splanchnic artery perfusion.
Read the detailed description
Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on PETTICOAT technique.
- Conditions
- Aortic Dissection
- Being tested
- Fabulous Thoracic Aortic Stent System
- Keywords
- Stent Graft
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fabulous Thoracic Aortic Stent SystemDevice
Endovascular treament in patients with aortic dissection with Fabulous Thoracic Aortic Stent System
| Study group | Role | What they receive |
|---|---|---|
| Fabulous Thoracic Aortic Stent System | Not described Receives: Device: Fabulous Thoracic Aortic Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of diameter
The changes of true lumen, false lumen and total aortic diameter before and after surgery in the level of pulmonary artery bifurcation/left atrial (L1), the distal end of covered stent (L2), superior mesenteric artery (L3) and abdominal aortic bifurcation (L4) were recorded.
Measured: 3 months, 6 months,12 months after operation
Changes of cross-sectional area
The changes of true lumen, false lumen and total aortic cross-sectional area before and after surgery in the level of pulmonary artery bifurcation/left atrial (L1), the distal end of covered stent (L2), superior mesenteric artery (L3) and abdominal aortic bifurcation (L4) were recorded.
Measured: 3 months, 6 months,12 months after operation
Volumetric change
The volumes of the true lumen and false lumen of the aorta before and after surgery were measured from the covered stent placement segment, the proximal end of the bare stent to the level of celiac trunk, from the level of celiac trunk to the level of low kidney, and from the level of low kidney to the abdominal aorta bifurcation.
Measured: 3 months, 6 months,12 months after operation
Secondary outcomes (7)
Splanchnic arteries perfusion
The change rate of postoperative true lumen diameter of branch artery = (postoperative true lumen diameter - preoperative true lumen diameter)/preoperative true lumen diameter ×100%
Measured: 3 months, 6 months,12 months after operation
Incidence of distal new entry
The number of visceral artery segment tears and infrarenal abdominal aorta segment tears were evaluated.
Measured: 3 months, 6 months,12 months after operation
Tortuosity of the descending thoracic aorta
Tortuosity of the descending thoracic aorta = the length of left subclavian artery to descending aorta of coeliac trunk along the center lumen line/the outer curvature length of left subclavian artery to coeliac trunk
Measured: 3 months, 6 months,12 months after operation
Immediate technical success
Immediate technical success was defined as the stent was successfully delivered to the intended site and released.
Measured: Immediate during surgery
Incidence of type I and III endoleak
Measured: Immediate during surgery,3 months, 6 months,12 months after operation
Major adverse events occurring within 30 days after surgery
Refers to all-cause mortality, myocardial infarction, ischemic stroke or respiratory failure occurring within 30 days after surgery. More specifically, myocardial infarction refers to a drastic reduction or complete interruption of the coronary blood supply due to coronary artery disease, resulting in severe and prolonged acute ischemia of the corresponding myocardium, leading to necrosis of cardiomyocytes. Ischemic stroke refers to the end result of necrosis of brain tissue caused by narrowing or occlusion of the arteries supplying blood to the brain or insufficient blood supply to the brain. Respiratory failure is defined as a state resulting in significantly prolonged intubation, tracheotomy, deterioration of lung function, or other fatal outcomes.
Measured: within 30 days after operation
Incidence of severe adverse events
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Measured: 3 months, 6 months,12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (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.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883592
- Sponsor's protocol ID
- Fabulous WQ-F01
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- 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 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study on Distal Aortic Remodeling for Stanford Type B Aortic Dissection With Fabulous Thoracic Aortic Stent System
- ClinicalTrials.gov ID
- NCT05883592
- Acronym / sponsor ID
- Fabulous WQ-F01
- Conditions
- Aortic Dissection
- Keywords
- Stent Graft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 1 Jun 2023 (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.
To evaluate aortic remodeling of Fabulous thoracic aortic stent system in the treatment of acute and subacute Stanford type B aortic dissection (the changes of aortic diameter, cross-sectional area,and volume of true lumen, false lumen and total aorta in different aoritc levels, and false lumen thrombosis in different aoritc levels), and splanchnic artery perfusion.
Detailed description
Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on PETTICOAT technique.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fabulous Thoracic Aortic Stent System | – | Device: Fabulous Thoracic Aortic Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Stanford type B aortic dissection are treated with Fabulous Thoracic Aortic Stent System in the real world.
Key inclusion criteria (7 listed)
- ≥18 years old, regardless of gender;
- Fabulous thoracic aortic stent System is suitable for the treatment of acute or subacute Stanford type B dissection, and the lesions meet one of the following criteria:
- With appropriate arterial access and suitable for endovascular aortic repair;
- Subjects could understand the purpose of the trial, volunteered to participate in the study, signed the informed consent form by themselves or their legal representatives, and were willing to complete the follow-up as required by the protocol.
Key exclusion criteria (3 listed)
- Patients have participated in clinical trials of other drugs or medical devices related to target lesion treatment or have participated in clinical trials of other drugs or medical devices and have not reached the primary endpoint;
- Patients were unable or unwilling to participate in the study;
- Patients were judged by the investigator to be ineligible for participation in the trial.
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 |
|---|---|---|
| Fabulous Thoracic Aortic Stent SystemEndovascular treament in patients with aortic dissection with Fabulous Thoracic Aortic Stent System | Device | Fabulous Thoracic Aortic Stent System |
Primary outcome
Change of diameter
Time frame: 3 months, 6 months,12 months after operation
The changes of true lumen, false lumen and total aortic diameter before and after surgery in the level of pulmonary artery bifurcation/left atrial (L1), the distal end of covered stent (L2), superior mesenteric artery (L3) and abdominal aortic bifurcation (L4) were recorded.
Changes of cross-sectional area
Time frame: 3 months, 6 months,12 months after operation
The changes of true lumen, false lumen and total aortic cross-sectional area before and after surgery in the level of pulmonary artery bifurcation/left atrial (L1), the distal end of covered stent (L2), superior mesenteric artery (L3) and abdominal aortic bifurcation (L4) were recorded.
Volumetric change
Time frame: 3 months, 6 months,12 months after operation
The volumes of the true lumen and false lumen of the aorta before and after surgery were measured from the covered stent placement segment, the proximal end of the bare stent to the level of celiac trunk, from the level of celiac trunk to the level of low kidney, and from the level of low kidney to the abdominal aorta bifurcation.
7 secondary outcomes
Splanchnic arteries perfusion
Time frame: 3 months, 6 months,12 months after operation
Incidence of distal new entry
Time frame: 3 months, 6 months,12 months after operation
Tortuosity of the descending thoracic aorta
Time frame: 3 months, 6 months,12 months after operation
Immediate technical success
Time frame: Immediate during surgery
Incidence of type I and III endoleak
Time frame: Immediate during surgery,3 months, 6 months,12 months after operation
Major adverse events occurring within 30 days after surgery
Time frame: within 30 days after operation
Incidence of severe adverse events
Time frame: 3 months, 6 months,12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- 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. This study is not recruiting at the moment.
Xi Guo contact
2 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, run by Hangzhou Endonom Medtech Co., Ltd. at 2 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 7 inclusion and 3 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 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Xi Guo (13911048625, happyfred2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of diameter (time frame: 3 months, 6 months,12 months after operation). 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 1 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.