Aortic Arch AneurysmNCT04765592
Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study)
A study testing WeFlow-Arch Modeler Embedded Branch Stent Graft System in people with Aortic Arch Aneurysm, run by Hangzhou Endonom Medtech Co., Ltd. at 23 sites in China.
Trial summary
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/false aortic arch aneurysms and ulcers involving aortic arch . (GIANT 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-Arch Modeler Embedded Branch Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 23 sitesChina
- Study dates
- 7 Jun 2021to 5 Feb 2029
- 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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- Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
- Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
- 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.
- Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications.
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 carotid or subclavian artery;
- Heart transplant;
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- Suffered MI 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); thrombocytopenia (PLT count < 50 × 109/L), history of bleeding or coagulopathy;
- Renal insufficiency， creatinine > 265 umol/L (or 3.0mg/dL) and/or end-stage renal disease requiring renal dialysis, as determined by an investigator after a thorough analysis;
- 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
23 sites in 1 country.
23 sites in 1 country
China23 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing
Chinese PLA General Hospital
Beijing
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
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 ,Sun Yat-sen University
Guangzhou
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
The Second Affiliated Hospital of Harbin Medical University
Harbin
Shandong Provincial Hospital
Jinan
The First People's Hospital of Yunnan Province
Kunming
Nanjing Drum Tower Hospital
Nanjing
Nanjing First Hospital
Nanjing
The Affiliated Hospital Of Qingdao University
Qingdao
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Zhongshan Hospital, Fudan University
Shanghai
The First Affiliated Hospital of China Medical University
Shenyang
The First Affiliated Hospital Of Soochow University
Suzhou
Tianjin Medical University General Hospital
Tianjin
The First Affiliated Hospital of PLA Air Force Military Medical University
Xi'an
First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/false aortic arch aneurysms and ulcers involving aortic arch . (GIANT Study)
Read the detailed description
This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System, it is expected to complete the implantation of 80 patients in 23 centers within 12 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 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively.
- Conditions
- Aortic Arch Aneurysm
- Being tested
- WeFlow-Arch Modeler Embedded Branch 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-Arch Modeler Embedded Branch Stent Graft SystemDevice
The modular embedded aortic arch stent graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system and the branch stent system.
| Study group | Role | What they receive |
|---|---|---|
| WeFlow-Arch Modeler Embedded Branch Stent Graft System | Experimental | Participants will be treated with WeFlow-Arch Modeler Embedded Branch Stent Graft System Receives: Device: WeFlow-Arch Modeler Embedded Branch 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 per imaging studies conducted at the end of the procedure with all branching stents patency.
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
Incidence of Type I or Type III endoleak before discharge, 1 month, 6 months, 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: immediately after the surgery, 1 month, 6 months, 12 months after the surgery
Incidence of aortic arch stent graft displacement
CTA examination will be performed at 1 month, 6 months, and 12 months post 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 from pre-discharge levels.
Measured: 1 month, 6 months, 12 months after operation
Postoperative branch vessel patency rate
CTA examinations will be performed at 1 month, 6 months, and 12 months post operation to evaluate branch vessel reconstruction and assess for occlusion, stenosis, or in-stent thrombosis.
Measured: 1 month, 6 months, 12 months after operation
Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention
Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention 30 days, 6 months, and 12 months after operation.Whether or not the patient experienced surgically induced de novo aortic dissection converted to open-heart surgery 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 post operation
Rate of aortic aneurysm-related mortality
Refers to mortality caused by a ruptured aortic aneurysm or endovascular interventional treatment.
Measured: 12 months post 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 one or more 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, or of indeterminate relationship, 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 posted21 Feb 2021
- Study start7 Jun 2021
- Primary completion5 Feb 2025 (estimated)
- Study completion5 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 88 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
- NCT04765592
- Sponsor's protocol ID
- WEIQIANG202001
- Status last verified
- Apr 2024
- First submitted
- 4 Feb 2021
- Last updated
- 30 Apr 2024
- 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.
Publications
Liu F, Zhang H, Rong D, Ge Y, Jia X, Xiong J, Ma X, Wang L, Fan T, Guo W. Protocol for Guo's aortIc Arch recoNstrucTion: a prospective, multicentre and single-arm study to evaluate the safety and efficacy of the WeFlow-Arch modular inner branch stent-graft system for aortic arch lesions (GIANT study). BMJ Open. 2022 Oct 10;12(10):e063245. doi: 10.1136/bmjopen-2022-063245.
PubMed 36216431
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study)
- ClinicalTrials.gov ID
- NCT04765592
- Acronym / sponsor ID
- WEIQIANG202001
- Conditions
- Aortic Arch Aneurysm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 5 Feb 2025 (estimated)
- Study completion
- 5 Feb 2029 (estimated)
- First posted
- 21 Feb 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 ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/false aortic arch aneurysms and ulcers involving aortic arch . (GIANT Study)
Detailed description
This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System, it is expected to complete the implantation of 80 patients in 23 centers within 12 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 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months 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-Arch Modeler Embedded Branch Stent Graft System | Experimental | Device: WeFlow-Arch Modeler Embedded Branch Stent Graft SystemParticipants will be treated with WeFlow-Arch Modeler Embedded Branch 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 (11 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.
- Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications.
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 carotid or subclavian artery;
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-Arch Modeler Embedded Branch Stent Graft SystemThe modular embedded aortic arch stent graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system and the branch stent system. | Device | WeFlow-Arch Modeler Embedded Branch 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: immediately after the surgery, 1 month, 6 months, 12 months after the surgery
Incidence of aortic arch stent graft displacement
Time frame: 1 month, 6 months, 12 months after operation
Postoperative branch vessel patency rate
Time frame: 1 month, 6 months, 12 months after operation
Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention
Time frame: 30 days, 6 months, and 12 months after operation
Rate of major adverse events
Time frame: 30 days post operation
Rate of aortic aneurysm-related mortality
Time frame: 12 months post 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 30 Apr 2024.
- Derived from this study: PubMed 36216431Liu F, Zhang H, Rong D, Ge Y, Jia X, Xiong J, Ma X, Wang L, Fan T, Guo W. Protocol for Guo's aortIc Arch recoNstrucTion: a prospective, multicentre and single-arm study to evaluate the safety and efficacy of the WeFlow-Arch modular inner branch stent-graft system for aortic arch lesions (GIANT study). BMJ Open. 2022 Oct 10;12(10):e063245. doi: 10.1136/bmjopen-2022-063245.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeFlow-Arch Modeler Embedded Branch Stent Graft System in people with Aortic Arch Aneurysm, run by Hangzhou Endonom Medtech Co., Ltd. at 23 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 11 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
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?
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?
On the ClinicalTrials.gov record for NCT04765592, which also lists 1 linked publication.
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 30 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.