Aortic Dissection Type BNCT04918212
Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection
A study testing Fabulous Stent Graft System in people with Aortic Dissection Type B, run by Hangzhou Endonom Medtech Co., Ltd. at 24 sites in China.
Trial summary
A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of Fabulous Stent Graft System manufactured by Hangzhou Endonom Medtech Co., Ltd. for Stanford B Aortic Dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection Type B
- What is being tested?
- Fabulous Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 24 sitesChina
- Study dates
- 25 Nov 2017to 13 Oct 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patients ≥18 years old;
- The informed consent was signed by the patient or the legal representative;
- Diagnosed with Stanford B aortic dissection;
- The proximal anchoring area of is 18-42 mm in diameter, and not less than 15mm in length;
- Has a suitable arterial approach and is suitable for surgical treatment.
Who cannot join
- The patient's distal vascular false cavity has been completely thrombotic or organized;
- Pregnant or breastfeeding ;
- Has participated in clinical trials of other devices ；
- History of aortic surgery or endovascular repair surgery ;
- Allergic to contrast agents and anesthetics ;
- Allergic to stents or conveyors ;
Show all 10Show fewer
- Patients with true or false aortic aneurysm;
- History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
- Life expectancy is less than 12 months;
- Other situations in which the investigator judges that not suitable for endovascular treatment .
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
Beijing Friendship Hospital, Capital Medical University
Beijing
Chinese People's Liberation Army General Hospital
Beijing
Peking University People's Hospital
Beijing
Xiangya Hospital of Central South University
Changsha
West China Hospital of Sichuan University
Chengdu
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Guangdong Provincial People's Hospital
Guangzhou
Hainan Provincial People's Hospital
Haikou
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Anhui Provincial Hospital
Hefei
The First Affiliated Hospital of Kunming Medical College
Kunming
Liuzhou Workers' Hospital
Liuzhou
The Second Affiliated Hospital of Nanchang University
Nanchang
Jiangsu Provincial People's Hospital
Nanjing
The First Affiliated Hospital of Guangxi Medical University
Nanning
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai
Zhongshan Hospital Affiliated to Fudan University
Shanghai
The First Hospital of Hebei Medical University
Shijia Zhuang
Tianjin Medical University General Hospital
Tianjin
The First Affiliated Hospital of the Fourth Military Medical University
Xi'an
Yantai Yuhuangding Hospital
Yantai
First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan Provincial People's Hospital
Zhengzhou
About this study
Official title: Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection: A Prospective, Multi-center, Single Arm, Objective Performance Criteria Clinical Trial
A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of Fabulous Stent Graft System manufactured by Hangzhou Endonom Medtech Co., Ltd. for Stanford B Aortic Dissection.
- Conditions
- Aortic Dissection Type B
- Being tested
- Fabulous Stent Graft System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fabulous Stent Graft SystemDevice
All patients received endovascular surgery using fabulous stent graft system
| Study group | Role | What they receive |
|---|---|---|
| Fabulous Stent Graft System | Experimental | All patients received endovascular surgery using fabulous stent graft system Receives: Device: Fabulous Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with no incidence of major surgical or device related adverse events rate
Surgical or device related major adverse events (MAE) : death, respiratory failure, renal failure, stroke, paraplegia, intestinal ischemia, cardiovascular and vascular complications caused by surgery or device
Measured: within 30 days after surgery
Clinical success rate
Clinical success is defined as : no displacement of Stent Graft System, no type I or III endoleak requiring treatment, no enlargement of the false lumen, thrombosis of the false lumen, and no rupture of the dissection
Measured: 12 months after surgery
Secondary outcomes (5)
adverse event rate
Measured: within 12 months after surgery
Immediate delivery success rate
The stent graft system was successfully transported to the correct position and released successfully
Measured: immediately after the surgery
Immediate operation successful rate
After the operation, angiographic observation showed that the proximal covered stent was in an appropriate position and adhered well without obvious endoleak, while the distal bare stent was in an appropriate position and adhered well
Measured: immediately after the surgery
Endoleak rate
Measured: within 12 months after surgery
Secondary surgical treatment rate
Secondary endovascular or surgical treatment due to stent displacement, endoleak, or related complications after stent implantation
Measured: within 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start25 Nov 2017
- Primary completion13 Oct 2020
- Study completion13 Oct 2020
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
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
- NCT04918212
- Sponsor's protocol ID
- WQ1601
- Status last verified
- Nov 2021
- First submitted
- 2 Jun 2021
- Last updated
- 8 Nov 2021
- 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 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection: A Prospective, Multi-center, Single Arm, Objective Performance Criteria Clinical Trial
- ClinicalTrials.gov ID
- NCT04918212
- Acronym / sponsor ID
- WQ1601
- Conditions
- Aortic Dissection Type B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2017 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 8 Jun 2021 (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 prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of Fabulous Stent Graft System manufactured by Hangzhou Endonom Medtech Co., Ltd. for Stanford B Aortic Dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fabulous Stent Graft System | Experimental | Device: Fabulous Stent Graft SystemAll patients received endovascular surgery using fabulous stent graft system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥18 years old;
- The informed consent was signed by the patient or the legal representative;
- Diagnosed with Stanford B aortic dissection;
- The proximal anchoring area of is 18-42 mm in diameter, and not less than 15mm in length;
- Has a suitable arterial approach and is suitable for surgical treatment.
Key exclusion criteria (10 listed)
- The patient's distal vascular false cavity has been completely thrombotic or organized;
- Pregnant or breastfeeding ;
- Has participated in clinical trials of other devices ；
- History of aortic surgery or endovascular repair surgery ;
- Allergic to contrast agents and anesthetics ;
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 Stent Graft SystemAll patients received endovascular surgery using fabulous stent graft system | Device | Fabulous Stent Graft System |
Primary outcome
Number of patients with no incidence of major surgical or device related adverse events rate
Time frame: within 30 days after surgery
Surgical or device related major adverse events (MAE) : death, respiratory failure, renal failure, stroke, paraplegia, intestinal ischemia, cardiovascular and vascular complications caused by surgery or device
Clinical success rate
Time frame: 12 months after surgery
Clinical success is defined as : no displacement of Stent Graft System, no type I or III endoleak requiring treatment, no enlargement of the false lumen, thrombosis of the false lumen, and no rupture of the dissection
5 secondary outcomes
adverse event rate
Time frame: within 12 months after surgery
Immediate delivery success rate
Time frame: immediately after the surgery
Immediate operation successful rate
Time frame: immediately after the surgery
Endoleak rate
Time frame: within 12 months after surgery
Secondary surgical treatment rate
Time frame: within 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fabulous Stent Graft System in people with Aortic Dissection Type B, run by Hangzhou Endonom Medtech Co., Ltd. at 24 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 5 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: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with no incidence of major surgical or device related adverse events rate (time frame: within 30 days after surgery). 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 8 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.