Aortic Arch AneurysmNCT06520774
Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
A study testing Concave Supra-arch Branched Stent-Graft System in people with Aortic Arch Aneurysm and Penetrating Aortic Ulcer, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 17 sites in 2 countries.
Trial summary
The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Arch Aneurysm, Penetrating Aortic Ulcer
- What is being tested?
- Concave Supra-arch Branched Stent-Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 30 May 2024to 30 Jun 2031
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are aged 18 to 80 years inclusive；
- Patients diagnosed with aortic arch aneurysms or penetrating ulcers that require intervention, and for whom the proximal end of the stent needs to be anchored in the Z0 zone;
- Anatomical criteria, including:
- Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
- The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 30 mm;
- The diameter of the anchored area of supra-arch branch vessels (innominate artery, left common carotid artery, left subclavian artery) is between 5-18 mm, distal anchorage length is greater than or equal to 15 mm;
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- Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;
- Have a suitable iliac, femoral, and superior arch arterial access;
- At least two researchers should assess that the subject is a high-risk patient for surgical treatment or has significant contraindications to surgery. It is recommended to refer to the following criteria: a score of ≥6 in the European System for Cardiac Operative Risk Evaluation (EuroSCORE) scoring system.;
- Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up visits as required by the protocol.
Who cannot join
- Patients either with ruptured or infected aneurysms;
- Patients with aortic dissection;
- Patients with general or local infections that may increase the risk of endovascular graft infection;
- Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to impede stent-graft adherence or affect stent patency;
- Previous endovascular intervention involving the aortic arch;
- Underwent open or endovascular surgery for abdominal aorta within the past 3 months;
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- Patients with a history of stroke within the past 3 months (excluding TIA);
- Patients with aneurysms involving the distal descending aorta and requiring reconstruction of important visceral branch vessels within the abdomen;
- Patients with a history of myocardial infarction within the past 3 months;
- Patients with congestive heart failure - NYHA Class IV;
- Patients allergic to contrast agents, stent and delivery system materials (such as nitinol, polyester, PTFE, nylon polymer materials);
- Patients with contraindications to anticoagulant or antiplatelet drugs;
- Patients unable to tolerate general anesthesia;
- Patients with abnormal liver and kidney function before surgery (ALT or AST more than 5 times the upper limit of normal; serum creatinine (Cr) >150umol/L);
- Patients with connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;
- Patients with arteritis;
- Patients with a life expectancy of less than 1 year;
- Women who are planning to conceive, pregnant or breastfeeding;
- Patients deemed by the investigator as unsuitable for endovascular treatment;
- Patients who have participated in other clinical studies and have not withdrawn or been excluded within the 3 months prior to the screening period of this study.
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Martin Czerny, Professor contact
17 sites in 2 countries
China16 sites, 16 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing
chang shu, Professor
- Recruiting
Second Xiangya Hospital of Central South University
Changsha
chang shu, Professor
- Recruiting
West China Hospital, Sichuan University
Chengdu
Jia Hu, Professor
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Fanggang Cai, Professor
- Recruiting
Union Hospital Affiliated to Fujian Medical University
Fuzhou
Liangwan Chen, Professor
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou
Hongkun Zhang, Professor
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming
Bin Yang, Professor
- Recruiting
The First People's Hospital of Yunnan Province
Kunming
Kunmei Gong, Professor
- Recruiting
Yunnan Fuwai Cardiovascular Disease Hospital
Kunming
Yuanyuan Guo, Professor
- Recruiting
Jiangsu Provincial People's Hospital
Nanjing
Xiwei Zhang, Professor
- Recruiting
Nanjing First Hospital
Nanjing
Xin Chen, Professor
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai
Weiguo Fu, Professor
- Recruiting
Shenzhen Hospital of Fuwai Hospital of Chinese Academy of Medical Sciences
Shenzhen
Chang Shu, Professor
- Recruiting
Renmin Hospital of Wuhan University
Wuhan
Jun Xia, Professor
- Recruiting
Cardiovascular Disease Hospital Affiliated to Xiamen University
Xiamen
Hui Zhuang, Professor
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Zhen Li, Professor
Germany1 site, 1 recruiting
- Not yet recruiting
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau
Martin Czerny, Professor, martin.czerny@uniklinik-freiburg.de
About this study
Official title: A Prospective, Multicenter, Single-Group Target-Value Clinical Trial: Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Read the detailed description
The physician must strictly adhere to the clinical study protocol and shall not deviate from or substantially alter it. However, in cases of emergency where there is an immediate risk to the subjects that must be eliminated immediately, a report may be submitted in written form afterward. During the study, any amendments to the clinical study protocol, informed consent documents, requests for deviation, and the resumption of a suspended clinical study must receive written approval from the Ethics Committee.
- Conditions
- Aortic Arch Aneurysm, Penetrating Aortic Ulcer
- Being tested
- Concave Supra-arch Branched Stent-Graft System
- Keywords
- Lifetech, Concave Supra-arch Branched Stent-Graft System, Endovascular Treatment
- Medical subject headings
- Aneurysm, Aortic Arch, Penetrating Atherosclerotic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concave Supra-arch Branched Stent-Graft SystemDevice
To evaluate the efficacy and safety of Concave Supra-arch Branched Stent-Graft System for endovascular treatment of Aortic Arch Diseases
| Study group | Role | What they receive |
|---|---|---|
| Concave Supra-arch Branched Stent-Graft System | Experimental | Endovascular treatment of patients with Aortic Arch Diseases using Concave Supra-arch Branched Stent-Graft System Receives: Device: Concave Supra-arch Branched Stent-Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of composite endpoints
Composite endpoints refer to the occurrence of any of the following within 30 days post-surgery: all-cause mortality, disabling stroke, or permanent paraplegia.
Measured: within 30 days post-surgery
The clinical treatment success rate within 12 months
The 12-month clinical treatment success rate is a composite endpoint that includes immediate technical success after surgery and the absence of the following conditions at 12 months postoperatively: death, displacement of the aortic or branch covered stents on CTA follow-up, Type I or III endoleak, branch stent occlusion, and the need for secondary surgical intervention during the follow-up period.
Measured: pre-discharge (up to 14 days) and 12 months postoperatively
Secondary outcomes (13)
Immediate technical success rate
Immediate technical success refers to the successful delivery of the delivery system to the predetermined position, successful deployment of the system, safe removal of the delivery system from the body, and absence of type I and III endoleaks that require intervention on angiography at the end of the procedure, with all branch stents being patent.
Measured: Immediate intraoperative
Incidence of increase in the maximum diameter of the aneurysm/depth of ulceration by more than 5 mm at 6 months and 12 months postoperatively.
Increase in the maximum diameter of the aneurysm/depth of ulceration> 5 mm
Measured: 6 and 12 months postoperatively
Incidence rate of Type I/III endoleak at Intraoperative, pre-discharge, 6 and 12 months postoperatively
A Type I endoleak occurs when there is a gap between the graft and the vessel wall at the "seal zones." This gap allows blood to flow alongside the graft into the aneurysm sac, creating pressure within the sac and increasing the risk of rupture. Type I endoleaks often occur when the aneurysm's anatomy is unsuitable for endovascular aneurysm repair (EVAR) or due to inappropriate device selection. However, vessel dilation over time can also cause this type of endoleak. Immediate attention is typically required because of the high risk of sac enlargement and rupture.
A Type III endoleak results from a defect or misalignment between the components of the endograft. Similar to a Type I endoleak, a Type III endoleak causes systemic pressure within the aneurysm sac, increasing the risk of rupture. Consequently, Type III endoleaks also necessitate urgent attention.
The definition of "pre-discharge" is either the discharge date or the 14th postoperative day, whichever occurs first.
Measured: Intraoperative, pre-discharge（up to 14 days）, 6 and 12 months postoperatively
Incidence rate of stent graft migration at 6 and 12 months postoperatively
Migration is defined according to reporting standards as a stent graft shift of more than 10 mm relative to a primary anatomic landmark, or any displacement that results in symptoms or necessitates therapy. A standardized measurement protocol was employed in accordance with the reporting guidelines.
Measured: 6 and 12 months postoperatively
The patency rate of the branch vessel at 6 and 12 months postoperatively
Branch vessel patency is defined as stenosis of ≤50%
Measured: 6 and 12 months postoperatively
Incidence rate of secondary surgical interventions related to the aortic arch and its branch arteries before discharge , at the 6 months and 12 months , and at 2-5 years postoperatively
Incidence of secondary surgical interventions related to the aortic arch and its branch arteries
Measured: before discharge （up to 14 days）, at the 6 months and 12 months , and at 2-5 years postoperative
Incidence rate of aneurysm rupture at Intraoperative, pre-discharge, 6 and 12 months, 2-5 years postoperatively
An aneurysm is an abnormal bulge or ballooning in the wall of a blood vessel. If an aneurysm ruptures, it causes internal bleeding, which can often be fatal.
Measured: Intraoperative, pre-discharge (up to 14 days）, 6 and 12 months 2-5 years postoperatively
Incidence rate of delivery system-related complications during perioperative period (from surgery to 30 days after surgery)
The incidence rate of related complications during the perioperative period (from surgery to 30 days post-surgery) includes intraoperative conversion surgeries due to delivery devices, as well as bleeding, hematoma, and pseudoaneurysm occurring along the delivery access route.
Measured: perioperative period (from surgery to 30 days after surgery)
Incidence rate of MAE at Intraoperative, pre-discharge and within 30 days postoperatively
A Major Adverse Event (MAE) is defined as any occurrence of all-cause mortality, intestinal necrosis, kidney failure, stroke (excluding TIA), permanent paraplegia, myocardial infarction, or respiratory failure.
Measured: Intraoperative, pre-discharge（up to 14 days） and within 30 days postoperatively
All-cause mortality at 6 months, 12 months, and 2-5 years postoperatively
All-cause mortality refers to the rate of death from any cause within a specific population over a defined period of time.
Measured: 6 months, 12 months, and 2-5 years postoperatively
Aortic-related mortality at 6 months, 12 months, and 2-5 years postoperatively
Aortic-related mortality refers to the proportion of deaths attributed to aortic conditions within a specific population over a defined period of time.
Measured: 6 months, 12 months, and 2-5 years postoperatively
Incidence rate of severe adverse events at 6 months, 12 months, and 2-5 years postoperatively
A serious adverse event (SAE) in a clinical trial refers to any incident that results in death or a significant deterioration in health. This includes life-threatening illnesses or injuries, permanent impairment of a body structure or function, hospitalization or extended hospital stay, and medical or surgical interventions necessary to prevent permanent damage to physical structure or function. Additionally, SAEs encompass events causing fetal distress, fetal death, or congenital anomalies or defects.
Measured: 6 months, 12 months, and 2-5 years postoperatively
Incidence rate of Device-related adverse events at 6 months, 12 months, and 2-5 years postoperatively
Medical device adverse events are unexpected incidents that occur during or after the use of a medical device by a patient. The World Health Organization (WHO) defines an adverse event as "a problem that can or does result in permanent impairment, injury, or death to the patient or the user." This definition implies two key requirements for determining a medical device adverse event. First, the event must be related to the usage of the medical device. Second, it must be assessed whether the use of the medical device could cause direct harm or potential harm.
Measured: 6 months, 12 months, and 2-5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start30 May 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Arch AneurysmStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Second Xiangya Hospital of Central South University
- Responsible party
- Sponsor
- Investigators
- chang shu, Professor, Principal investigator, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520774
- Sponsor's protocol ID
- P134-01
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2024
- Last updated
- 28 Jul 2025
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Group Target-Value Clinical Trial: Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
- ClinicalTrials.gov ID
- NCT06520774
- Acronym / sponsor ID
- P134-01
- Conditions
- Aortic Arch Aneurysm, Penetrating Aortic Ulcer
- Keywords
- Lifetech, Concave Supra-arch Branched Stent-Graft System, Endovascular Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Second Xiangya Hospital of Central South University
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 25 Jul 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.
The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Detailed description
The physician must strictly adhere to the clinical study protocol and shall not deviate from or substantially alter it. However, in cases of emergency where there is an immediate risk to the subjects that must be eliminated immediately, a report may be submitted in written form afterward. During the study, any amendments to the clinical study protocol, informed consent documents, requests for deviation, and the resumption of a suspended clinical study must receive written approval from the Ethics Committee.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concave Supra-arch Branched Stent-Graft System | Experimental | Device: Concave Supra-arch Branched Stent-Graft SystemEndovascular treatment of patients with Aortic Arch Diseases using Concave Supra-arch Branched Stent-Graft System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who are aged 18 to 80 years inclusive；
- Patients diagnosed with aortic arch aneurysms or penetrating ulcers that require intervention, and for whom the proximal end of the stent needs to be anchored in the Z0 zone;
- Anatomical criteria, including:
- At least two researchers should assess that the subject is a high-risk patient for surgical treatment or has significant contraindications to surgery. It is recommended to refer to the following criteria: a score of ≥6 in the European System for Cardiac Operative Risk Evaluation (EuroSCORE) scoring system.;
- Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up visits as required by the protocol.
Key exclusion criteria (20 listed)
- Patients either with ruptured or infected aneurysms;
- Patients with aortic dissection;
- Patients with general or local infections that may increase the risk of endovascular graft infection;
- Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to impede stent-graft adherence or affect stent patency;
- Previous endovascular intervention involving the aortic arch;
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 |
|---|---|---|
| Concave Supra-arch Branched Stent-Graft SystemTo evaluate the efficacy and safety of Concave Supra-arch Branched Stent-Graft System for endovascular treatment of Aortic Arch Diseases | Device | Concave Supra-arch Branched Stent-Graft System |
Primary outcome
Incidence of composite endpoints
Time frame: within 30 days post-surgery
Composite endpoints refer to the occurrence of any of the following within 30 days post-surgery: all-cause mortality, disabling stroke, or permanent paraplegia.
The clinical treatment success rate within 12 months
Time frame: pre-discharge (up to 14 days) and 12 months postoperatively
The 12-month clinical treatment success rate is a composite endpoint that includes immediate technical success after surgery and the absence of the following conditions at 12 months postoperatively: death, displacement of the aortic or branch covered stents on CTA follow-up, Type I or III endoleak, branch stent occlusion, and the need for secondary surgical intervention during the follow-up period.
13 secondary outcomes
Immediate technical success rate
Time frame: Immediate intraoperative
Incidence of increase in the maximum diameter of the aneurysm/depth of ulceration by more than 5 mm at 6 months and 12 months postoperatively.
Time frame: 6 and 12 months postoperatively
Incidence rate of Type I/III endoleak at Intraoperative, pre-discharge, 6 and 12 months postoperatively
Time frame: Intraoperative, pre-discharge（up to 14 days）, 6 and 12 months postoperatively
Incidence rate of stent graft migration at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
The patency rate of the branch vessel at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
Incidence rate of secondary surgical interventions related to the aortic arch and its branch arteries before discharge , at the 6 months and 12 months , and at 2-5 years postoperatively
Time frame: before discharge （up to 14 days）, at the 6 months and 12 months , and at 2-5 years postoperative
Incidence rate of aneurysm rupture at Intraoperative, pre-discharge, 6 and 12 months, 2-5 years postoperatively
Time frame: Intraoperative, pre-discharge (up to 14 days）, 6 and 12 months 2-5 years postoperatively
Incidence rate of delivery system-related complications during perioperative period (from surgery to 30 days after surgery)
Time frame: perioperative period (from surgery to 30 days after surgery)
Incidence rate of MAE at Intraoperative, pre-discharge and within 30 days postoperatively
Time frame: Intraoperative, pre-discharge（up to 14 days） and within 30 days postoperatively
All-cause mortality at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively
Aortic-related mortality at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively
Incidence rate of severe adverse events at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively
Incidence rate of Device-related adverse events at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively
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 28 Jul 2025.
- 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.
Martin Czerny, Professor contact
chang shu, Professor principal investigator
Second Xiangya Hospital of Central South University
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concave Supra-arch Branched Stent-Graft System in people with Aortic Arch Aneurysm and Penetrating Aortic Ulcer, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 17 sites in 2 countries.
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 10 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China, Germany. 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?
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 chang shu, Professor (13607444222, changshu01@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite endpoints (time frame: within 30 days post-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 28 Jul 2025.