Aortic DissectionNCT05965271
A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection
An observational study of Aortic Dissection, run by Hangzhou Endonom Medtech Co., Ltd. at 7 sites in China.
Trial summary
A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous thoracic aortic stent system in the treatment of Stanford Type B aortic dissection. 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
- 260 participants
- Where
- 7 sitesChina
- Study dates
- 1 Aug 2023to Jan 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;
- Subject was diagnosed with Stanford Type B dissection and treated with Fabulous thoracic aortic stent system, including either a covered stent system, a bare stent, or both;
- 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
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing
Xi Guo
Central Hospital of Dalian University of Technology
Dalian, Liaoning
Xijing Zhuang
The First Affiliated Hospital Of Harbin Medical University
Harbin, Heilongjiang
Baodong Xie
The First People's Hospital of Yunnan Province
Kunming, Yunnan
Kunmei Gong
Fu Weiguo
Shanghai
Weiguo Fu
Shanghai Chest Hospital
Shanghai
Dan Zhu
Wuhan Asia General Hospital
Wuhan, Hubei
Zhendong Hua
About this study
A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous thoracic aortic stent system in the treatment of Stanford Type B aortic dissection.
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
- Aortic Dissection
- 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.
Major adverse events
Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia.
Measured: within 30 days after operation
Secondary outcomes (5)
Immediate technical success
Immediate technical success was defined as the stent was successfully delivered to the intended site and released.
Measured: Immediate during operation
Change of diameter
Changes of minimum diameter of true lumen, maximum diameter of false lumen and maximum total diameter of aorta before and after operation.
Measured: 30 days, 3 months,6 months after operation
Major adverse events
Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia.
Measured: 3 months,6 months after operation
All-cause death and dissection related death
All-cause deaths are defined as death from any cause during the follow-up. Dissection related death refers to death caused by rupture of aortic dissection or endovascular treatment of aortic dissection.
Measured: 3 months,6 months after operation
The incidence of reintervention
Thoracotomy or secondary intervention due to aortic dissection
Measured: 30 days, 3 months,6 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 posted28 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 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
- Retrospective
- Enrolment
- 260 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
- NCT05965271
- Sponsor's protocol ID
- Fabulous WQ-F02
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection
- ClinicalTrials.gov ID
- NCT05965271
- Acronym / sponsor ID
- Fabulous WQ-F02
- Conditions
- Aortic Dissection
- Keywords
- Aortic Dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 28 Jul 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.
A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous thoracic aortic stent system in the treatment of Stanford Type B aortic dissection.
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
- Retrospective
- 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 (4 listed)
- ≥18 years old, regardless of gender;
- Subject was diagnosed with Stanford Type B dissection and treated with Fabulous thoracic aortic stent system, including either a covered stent system, a bare stent, or both;
- 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
Major adverse events
Time frame: within 30 days after operation
Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia.
5 secondary outcomes
Immediate technical success
Time frame: Immediate during operation
Change of diameter
Time frame: 30 days, 3 months,6 months after operation
Major adverse events
Time frame: 3 months,6 months after operation
All-cause death and dissection related death
Time frame: 3 months,6 months after operation
The incidence of reintervention
Time frame: 30 days, 3 months,6 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 3 Aug 2023.
Related trials for Aortic Dissection
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingObservational study
Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
Aortic Dissection
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
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.
7 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 7 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 4 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Weiguo Fu, Professor (13801760929, fu.weiguo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse events (time frame: within 30 days after operation). 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 3 Aug 2023.