Aortic Arch AneurysmNCT06385379
Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)
A study testing WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system in people with Aortic Arch Aneurysm, run by Hangzhou Endonom Medtech Co., Ltd. at 20 sites in China.
Trial summary
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Arch Aneurysm
- What is being tested?
- WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 20 sitesChina
- Study dates
- 30 Jun 2024to 31 Dec 2030
- 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 aged 18 to 80 years old;
- Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
- Showing a suitable vascular condition, including:
- Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
- Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
- Proximal anchoring zone length ≥ 30 mm;
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- Branch arteries to be reconstructed were ≤ 24 mm and ≥ 6 mm in diameter and ≥ 20 mm in length;
- Suitable arterial access for endovascular interventional treatment;
- Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
- Subjects were assessed as high risk for surgery by at least two investigators or judged to have significant surgical contraindications. Recommended reference criteria were a European system for cardiac operative risk evaluation (EuroScore) score of 6 or higher or other surgical risk factors as judged by the physician team.
Who cannot join
- Experienced systemic infection during past three months;
- Neck surgery was performed within 3 months;
- Previous endovascular interventional treatment involving the aortic arch was performed;
- Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
- Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed;
- Heart transplant;
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- Suffered Myocardial Infarction or Stroke during past three months;
- Class IV heart function (NYHA classification);
- Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
- Hematological abnormality, defined as follows: Leukopenia (WBC < 3 ×109/L), acute anemia (Hb < 90 g/L), Coagulation disorders, thrombocytopenia (PLT count < 50 × 109/L);
- Renal insufficiency, creatinine > 150 umol/L and/or end-stage renal disease requiring renal dialysis;
- Pregnant or breastfeeding;
- Allergies to contrast agents;
- Life expectancy of less than 12 months;
- Participating in another drug or device research;
- Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites, 20 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
Zhong Chen
- Recruiting
Chinese PLA Gencral Hosptial
Beijing
Wei Guo, 13910758706
- Recruiting
The First Hospital of Jilin University
Changchun
Yongsheng Gao
- Recruiting
Xiangya Hospital of Central South University
Changsha
Wei Wang
- Recruiting
West China Hospital of Sichuan University
Chengdu
Jia Hu
- Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou
Xiaoping Fan
- Recruiting
The First Affiliated Hospital ,Sun Yat-sen University
Guangzhou
Guangqi Chang
- Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin
Baodong Xie
- Recruiting
Shandong Provincial Hospital
Jinan
Xuejun Wu
- Recruiting
The First People's Hospital of Yunnan Province
Kunming
Kunmei Gong
- Recruiting
The Second Affiliated Hospital Of Nanchang University
Nanchang
Weimin Zhou
- Recruiting
Nanjing First Hospital
Nanjing
Xin Chen
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Yongfeng Shao
- Recruiting
The Affiliated Hospital Of Qingdao University
Qingdao
Mingjin Guo
- Recruiting
Shanghai Chest Hospital
Shanghai
Dan Zhu
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai
Weiguo Fu
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang
Shijie Xin
- Recruiting
The First Affiliated Hospital of PLA Air Force Military Medical University
Xi'an
Jian Zuo
- Recruiting
Xiamen Cardiovascular Hospital
Xiamen
Xijie Wu
- Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou
Zhen Li
About this study
Official title: Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch Unique Embedded Aortic Triple-branch Arch Stent Graft System (GENIUS Study)
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)
Read the detailed description
This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System , it is expected to complete the implantation of 90 patients in 20 centers within 20 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24th month, 36th month, 48th month and 60th month postoperatively.
- Conditions
- Aortic Arch Aneurysm
- Being tested
- WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
- Medical subject headings
- Aneurysm, Aortic Arch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft systemDevice
The WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system, the aortic extension stent graft system and the branch stent system.
| Study group | Role | What they receive |
|---|---|---|
| WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system | Experimental | Participants will be treated with WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system Receives: Device: WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of all-cause mortality and major stroke within 12 months after surgery
All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset.
Measured: 12 months after surgery
Secondary outcomes (10)
Rate of immediate technical success following surgery
Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, and the absence of Type I and III endoleaks and all branching stents patency per imaging studies conducted at the end of the procedure .
Measured: immediately after the surgery
Rate of aortic aneurysm progression under control
Aortic aneurysm progression under control is defined as maximum increase in the diameter of the aortic aneurysm was ≤ 5 mm when compared with preoperative aortic aneurysm as of a 12-month postoperative CTA review.
Measured: 12 months after operation
Incidence of Type I or Type III endoleak
Endoleak detected by DSA or CTA during operation and at 1, 6, and 12 months after operation.
Intraoperative endoleaks subject to adjuvant treatment are not recorded. Endoleaks occurring after the completion of the procedure followed by one or more endoleaks occurring in the same subject at different follow-up stages that were not treated are counted as a single instance.
Measured: during operation and at 1, 6, and 12 months after operation
Incidence of aortic covered stent graft displacement
CTA examination will be performed at 6 months, and 12 months after operation to determine if the stent has migrated, and evaluations will be recorded for both the main and branch stents. Displacement is defined as a nodal aortic or branching stent graft displacement of more than 10 mm compared with that at postoperative day 30.
Measured: 6 months, 12 months after operation
Postoperative branch vessel patency rate
CTA examinations will be performed at 1 month, 6 months, and 12 months after operation to evaluate branch vessel reconstruction and assess for occlusion, stenosis, or in-stent thrombosis.
Measured: 1 month, 6 months, 12 months after operation
Rate of conversion to thoracotomy or secondary intervention
Whether or not the patient experienced surgically induced de novo aortic dissection converted to thoracotomy or secondary intervention will be determined.
Measured: 30 days, 6 months, and 12 months after operation
Rate of major adverse events
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 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: 30 days after surgery
Rate of aortic aneurysm-related mortality
Death due to aortic aneurysm rupture or endovascular treatment.
Measured: 12 months 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 permanent defects in body structure or body function.
Measured: 30 days, 6 months, and 12 months after operation
Incidence of device-related adverse events
Device-related adverse events refer to an adverse medical event related to the use of a device that occurs during the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event. Recording of device-related adverse events will be applicable for conditions that are deemed by the investigator to be definitely related, possibly related to the test device.
Measured: 30 days, 6 months, and 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 posted26 Apr 2024
- Study start30 Jun 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2030 (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.
- 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
- 90 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
- NCT06385379
- Sponsor's protocol ID
- WQ21-2301
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2024
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared for scientific purposes after the completion of the clinical trial. However, patients' electronic records and any CTA files are outside the scope of our data sharing policy. Researchers wanting to request data can submit a detailed application to the investigators. Data will be released depending on the scientific quality of the submitted request.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch Unique Embedded Aortic Triple-branch Arch Stent Graft System (GENIUS Study)
- ClinicalTrials.gov ID
- NCT06385379
- Acronym / sponsor ID
- WQ21-2301
- Conditions
- Aortic Arch Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Apr 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.
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)
Detailed description
This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System , it is expected to complete the implantation of 90 patients in 20 centers within 20 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24th month, 36th month, 48th month and 60th month postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system | Experimental | Device: WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft systemParticipants will be treated with WeFlow-Tribranch embedded aortic Triple-branch arch 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 aged 18 to 80 years old;
- Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
- Showing a suitable vascular condition, including:
- Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
- Subjects were assessed as high risk for surgery by at least two investigators or judged to have significant surgical contraindications. Recommended reference criteria were a European system for cardiac operative risk evaluation (EuroScore) score of 6 or higher or other surgical risk factors as judged by the physician team.
Key exclusion criteria (16 listed)
- Experienced systemic infection during past three months;
- Neck surgery was performed within 3 months;
- Previous endovascular interventional treatment involving the aortic arch was performed;
- Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
- Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed;
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 |
|---|---|---|
| WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft systemThe WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system, the aortic extension stent graft system and the branch stent system. | Device | WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system |
Primary outcome
Rate of all-cause mortality and major stroke within 12 months after surgery
Time frame: 12 months after surgery
All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset.
10 secondary outcomes
Rate of immediate technical success following surgery
Time frame: immediately after the surgery
Rate of aortic aneurysm progression under control
Time frame: 12 months after operation
Incidence of Type I or Type III endoleak
Time frame: during operation and at 1, 6, and 12 months after operation
Incidence of aortic covered stent graft displacement
Time frame: 6 months, 12 months after operation
Postoperative branch vessel patency rate
Time frame: 1 month, 6 months, 12 months after operation
Rate of conversion to thoracotomy or secondary intervention
Time frame: 30 days, 6 months, and 12 months after operation
Rate of major adverse events
Time frame: 30 days after surgery
Rate of aortic aneurysm-related mortality
Time frame: 12 months after operation
Incidence of severe adverse events
Time frame: 30 days, 6 months, and 12 months after operation
Incidence of device-related adverse events
Time frame: 30 days, 6 months, and 12 months after operation
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 1 May 2026.
- Individual participant dataSharing planned: Yes. The data will be shared for scientific purposes after the completion of the clinical trial. However, patients' electronic records and any CTA files are outside the scope of our data sharing policy. Researchers wanting to request data can submit a detailed application to the investigators. Data will be released depending on the scientific quality of the submitted request.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system in people with Aortic Arch Aneurysm, run by Hangzhou Endonom Medtech Co., Ltd. at 20 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 10 inclusion and 16 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
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 Wei Guo (13910758706, Pla301dml@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of all-cause mortality and major stroke within 12 months after surgery (time frame: 12 months after surgery). 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 May 2026.