Aortic DissectionNCT05430672
Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection
A study testing The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. ) in people with Aortic Dissection, run by Zhejiang Zylox Medical Device Co., Ltd. at 14 sites in China.
Trial summary
This is a prospective, multicenter and single-arm trail to study the safety and efficacy of the thoracic aortic stent graft system that specially designed for treating aortic dissection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 14 sitesChina
- Study dates
- Jun 2022to Aug 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years;
- Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent；
- Subjects who are diagnosed with Stanford type B aortic dissection requiring reconstruction of the left common carotid artery and left subclavian artery or requiring reconstruction of the left subclavian artery;
- Appropriate access to the femoral artery, iliac artery, brachial artery, etc. that can be used for endoluminal aortic therapy.
Who cannot join
- The same surgery requires intervention for other vascular lesions；
- History of surgery in the aortic arch or endovascular repair surgery;
- Severe stenosis or calcification or distortion in the anchoring area of the proximal end of the stent;
- Subjects with severe liver, kidney failure；
- Subjects with severe coagulation disorders；
- Female subjects who are pregnant, lactating within the study period or unable to contraception during the trail.
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- History of allergies to anesthetics, contrast agents or the material of stent/ deliver system；
- Inability to tolerate anesthesia；
- History of acute myocardial infarction, cerebral infarction or cerebral hemorrhage within 3 months before surgery;
- Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint.
- Subjects with acute systemic infection
- Other circumstances judged by researchers that are not suitable for enrollment .
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Peking Union Medical College Hospital
Beijing
Yuehong Zheng
The First Affiliated Hospital of Bengbu medical College
Bengbu, Anhui
Chaowen Yu
The First Hospital Of Zhejiang Province
Hanzhou, Zhejiang
Hongkun Zhang
The Second Hospital Of Anhui Medical University
Hefei, Anhui
Huaihe Hospital of Henan University
Kaifeng, Henan
Jianbo Che
Liuzhou Worker's Hospital
Liuzhou, Guangxi
Peiyong Hou
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
Weimin Zhou
Nanjing Drum Tower Hospital, the affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Xiaoqiang Li
Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
Shanghai
Xinwu Lu
Zhongshan Hospital
Shanghai
Weiguo Fu
The First Affiliated Hospital Of WMU
Wenzhou, Zhejiang
Jingyong Huang
Renmin Hospital Of Wuhan University
Wuhan, Hubei
Hongping Deng
The First Affiliated Hospital of Xi'An Jiaotong University
Xi'an, Shaanxi
Jianlin Liu
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan
Zhiwei Wang
About this study
Official title: A Prospective, Multicenter, Objective Performance Criteria-Controlled Study for National Medical Products Administration Approval Of The Thoracic Aortic Stent Graft System
This is a prospective, multicenter and single-arm trail to study the safety and efficacy of the thoracic aortic stent graft system that specially designed for treating aortic dissection.
Read the detailed description
This trail is conducted in several centers all around China. In about 18 months, 120 subjects with aortic dissection will be recruited, all of which receive endovascular treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ). The subjects will be followed up in 30 days/ 6 months/ 12 months/ 2-5 years.
- Conditions
- Aortic Dissection
- Being tested
- The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )
- Keywords
- Aortic Dissection, Thoracic aortic, 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.
The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )Device
This is a objective performance criteria-controlled study, all subjects meet the criteria will receive the same treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ).
| Study group | Role | What they receive |
|---|---|---|
| Subjects with aortic dissection | Other | Subjects receive endovascular treatment. Receives: Device: The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of no Major Adverse Event (MAE)
MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
Measured: Immediately after the intervention
Rate of no Major Adverse Event (MAE)
MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
Measured: 30 days
Success rate of endovascular treatment
- Technique success: the delivery system was successfully delivered to the predetermined position, the stent was accurately positioned and successfully deployed, and the delivery system could be safely withdrawn from the body, no type I or type III endoleak can be found during angiography.
- No stent displacement during 12 months follow up time.
- No secondary surgical intervention during 12 months follow up.
Measured: Up to 12 months
Secondary outcomes (7)
Rate of aortic dissection related mortality
Death caused by aortic dissection rupture or related treatment.
Measured: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of all cause mortality
Death for any reason will be recorded.
Measured: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of Adverse Events(AE)
The definition of AE(Adverse Event) refers to International Organization for Standardization (ISO) 14155, AE should be distinguished from normal postoperative stress response.
Measured: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of Serious Adverse Events(SAE)
The definition of SAE (Serious Adverse Event) refers to ISO 14155.
Measured: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of technique success
The delivery system was successfully delivered to the predetermined position, the stent was accurately positioned and successfully deployed, and the delivery system could be safely withdrawn from the body, no type I or type III endoleak can be found during angiography.
Measured: Immediately after the intervention
Incidence of stent displacement
Stent displacement was defined as the aortic and branch stent-grafts displacing by more than 10 mm from the post-implantation position.
Measured: 30 days/ 6 months/ 12 months
Success rate of endovascular repair
Comparison of CTA results before surgery and within 30 days, 6 months, and 12 months after surgery. Changes in the diameter of the stent covered by aortic dissection and thrombosis of the false lumen are used to determine whether the vessel is successfully repaired.
Measured: 30 days/ 6 months/ 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinwu Lu, Principal investigator, Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430672
- Sponsor's protocol ID
- V1.1/2021-11-16
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Objective Performance Criteria-Controlled Study for National Medical Products Administration Approval Of The Thoracic Aortic Stent Graft System
- ClinicalTrials.gov ID
- NCT05430672
- Acronym / sponsor ID
- V1.1/2021-11-16
- Conditions
- Aortic Dissection
- Keywords
- Aortic Dissection, Thoracic aortic, Stent graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 24 Jun 2022 (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 and single-arm trail to study the safety and efficacy of the thoracic aortic stent graft system that specially designed for treating aortic dissection.
Detailed description
This trail is conducted in several centers all around China. In about 18 months, 120 subjects with aortic dissection will be recruited, all of which receive endovascular treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ). The subjects will be followed up in 30 days/ 6 months/ 12 months/ 2-5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with aortic dissection | Other | Device: The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )Subjects receive endovascular treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80 years;
- Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent；
- Subjects who are diagnosed with Stanford type B aortic dissection requiring reconstruction of the left common carotid artery and left subclavian artery or requiring reconstruction of the left subclavian artery;
- Appropriate access to the femoral artery, iliac artery, brachial artery, etc. that can be used for endoluminal aortic therapy.
Key exclusion criteria (12 listed)
- The same surgery requires intervention for other vascular lesions；
- History of surgery in the aortic arch or endovascular repair surgery;
- Severe stenosis or calcification or distortion in the anchoring area of the proximal end of the stent;
- Subjects with severe liver, kidney failure；
- Subjects with severe coagulation disorders；
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 |
|---|---|---|
| The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )This is a objective performance criteria-controlled study, all subjects meet the criteria will receive the same treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ). | Device | Subjects with aortic dissection |
Primary outcome
Rate of no Major Adverse Event (MAE)
Time frame: Immediately after the intervention
MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
Rate of no Major Adverse Event (MAE)
Time frame: 30 days
MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
Success rate of endovascular treatment
Time frame: Up to 12 months
* Technique success: the delivery system was successfully delivered to the predetermined position, the stent was accurately positioned and successfully deployed, and the delivery system could be safely withdrawn from the body, no type I or type III endoleak can be found during angiography. * No stent displacement during 12 months follow up time. * No secondary surgical intervention during 12 months follow up.
7 secondary outcomes
Rate of aortic dissection related mortality
Time frame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of all cause mortality
Time frame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of Adverse Events(AE)
Time frame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of Serious Adverse Events(SAE)
Time frame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of technique success
Time frame: Immediately after the intervention
Incidence of stent displacement
Time frame: 30 days/ 6 months/ 12 months
Success rate of endovascular repair
Time frame: 30 days/ 6 months/ 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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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.
Xinwu Lu principal investigator
Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. ) in people with Aortic Dissection, run by Zhejiang Zylox Medical Device Co., Ltd. at 14 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 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: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 Jie Liang (13819565660, jie.liang@zyloxmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of no Major Adverse Event (MAE) (time frame: Immediately after the intervention). 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 24 Jun 2022.