Juxta Renal Abdominal Aortic Aneurysm Without RuptureNCT04745546
Guo's Visceral Arteries Reconstruction :The First in Man Study of WeFlow-JAAA Stent Graft System
A study testing WeFlow-JAAA Stent Graft System in people with Juxta Renal Abdominal Aortic Aneurysm Without Rupture, run by Hangzhou Endonom Medtech Co., Ltd. at 1 site in China.
Trial summary
This study is the First in Man Study of WeFlow-JAAA Stent Graft System manufactured by EndoNom Medtech(Hangzhou) Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Juxta Renal Abdominal Aortic Aneurysm Without Rupture
- What is being tested?
- WeFlow-JAAA Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2019to 1 Feb 2022
- 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
- 1.18 to 80 years old； 2.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; 3.Diagnosed as a perirenal abdominal aortic aneurysm, and need to reconstruct the superior mesenteric artery and both renal arteries blood supply； 4.The diameter of the proximal anchoring area (abdominal aorta at the lower edge of the superior mesenteric artery opening) is 18-34mm； 5.The upper edge of the aneurysmal body is more than 5mm from the lower edge of the superior mesenteric artery opening； 6.The distance between the bifurcation of the renal artery and the opening of the renal artery is more than 15mm, and the diameter range of the beginning of the renal artery is 5-8mm； 7.The twist angle of the proximal tumor neck (the angle between the long axis of the normal abdominal aorta and the long axis of the tumor neck) ≥120°； 8.With proper femoral artery, iliac artery, and brachial artery approach, aortic endovascular treatment can be performed.
Who cannot join
- Severe stenosis, calcification and mural thrombosis in the proximal anchoring area；
- Pregnant, breastfeeding or cannot contraception during the trial period;
- The patient has participated in clinical trials of other drugs or devices during the same period；
- Need to intervene in other vascular diseases (such as coronary artery and carotid artery) during the same operation and the postoperative drug treatment plan is affected；
- Have history of aortic surgery or endovascular repair surgery；
- Allergic to contrast agents, anesthetics, stents and delivery materials；
Show all 14Show fewer
- Cannot tolerate anesthesia；
- Severe liver, kidney, lung, and heart function abnormalities before surgery [Serum creatinine exceeds 2 times the upper limit of normal; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal ;Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination]；
- Ruptured abdominal aortic aneurysm, pseudo aortic aneurysm and dissecting aortic aneurysm；
- History of myocardial infarction, TIA or cerebral infarction within the past 3 months；
- Contraindications in the treatment of antiplatelet agents and anticoagulants；
- Life expectancy is less than 12 months (such as advanced malignant tumors)
- Acute systemic infection
- Investigator judged that not suitable for interventional treatment.
Trial locations and contacts
1 site in 1 country.
Jiang Cao contact
About this study
Official title: Guo's Visceral Arteries Reconstruction: The First in Man Study of WeFlow-JAAA Stent Graft System
This study is the First in Man Study of WeFlow-JAAA Stent Graft System manufactured by EndoNom Medtech(Hangzhou) Co., Ltd.
Read the detailed description
This clinical trial was conducted in a qualified clinical trial institution. Investigators will use WeFlow-JAAA Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. to treat patients with juxta renal abdominal aortic aneurysms. This is a Prospective, single-center, first in man study to evaluate the safety and effectiveness of abdominal aorta stent graft system in the treatment of patients with juxta renal abdominal aortic aneurysms. Follow-up will be conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery.
- Being tested
- WeFlow-JAAA Stent Graft System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeFlow-JAAA Stent Graft SystemDevice
The abdominal aorta stent graft system consists of the abdominal aorta embedded stent system, the abdominal aorta bifurcation stent system and the extended stent system. The abdominal aorta embedded stent has two embedded branch stents and two fenestrations. It can be combined with a peripheral small stent system of appropriate specifications to reconstruct the superior mesenteric artery, bilateral renal arteries and keep the abdominal trunk unobstructed. At the same time, the combination of the abdominal aorta embedded stent, the abdominal aorta bifurcation stent and the extended stent can solve the proximal renal and transrenal abdominal aortic aneurysm lesions with the upper edge of the abdominal aortic aneurysm body and the lower edge of the superior mesenteric artery opening ≥ 5 mm.
| Study group | Role | What they receive |
|---|---|---|
| WeFlow-JAAA Stent Graft System | Experimental | Participants will be treated with WeFlow-JAAA Stent Graft System Receives: Device: WeFlow-JAAA Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoint
No major adverse events related to device or surgery within 30 days after surgery :
Major adverse events within 30 days after surgery are all-cause death, myocardial infarction, renal failure, respiratory failure, ischemic stroke, intestinal necrosis, severe ischemia, or necrosis of lower limbs.
Measured: 30 days
Primary effective endpoint
Treatment success rate of abdominal aortic aneurysm 12 months after operation.
Measured: 12 months
Secondary outcomes (2)
Secondary safety endpoint
All-cause mortality, abdominal aortic aneurysm-related mortality, serious adverse events, device-related adverse events:
- All-cause mortality 30 days, 6 months, 12 months after operation.
- Abdominal aortic aneurysm related mortality 30 days, 6 months, 12 months after operation.
- The incidence of serious adverse events 30 days, 6 months, 12 months after operation.
- The incidence of device-related adverse events 30 days, 6 months, 12 months after operation.
Measured: 30 days, 6 months, 12 months
Secondary effective endpoint
The incidence of type I or type III endoleak, the incidence of stent graft displacement, the patency rate of branch vessels, the incidence of conversion to open surgery or secondary interventional surgery.
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 posted9 Feb 2021
- Study start28 Oct 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Feb 2022 (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 Juxta Renal Abdominal Aortic Aneurysm Without RuptureStudies 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
- 15 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
- NCT04745546
- Sponsor's protocol ID
- WeFlow-JAAA V1.0
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao JP, Zhang HP, Xiong J, Jia X, Ma XH, Wang LJ, Xu YL, Zhang MH, Guo W. First-in-Human Clinical Trial of the WeFlow-JAAA Endograft System in Patients With Juxtarenal Abdominal Aortic Aneurysms. J Endovasc Ther. 2025 Oct;32(5):1526-1537. doi: 10.1177/15266028231210480. Epub 2023 Nov 24.
PubMed 37997684
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guo's Visceral Arteries Reconstruction: The First in Man Study of WeFlow-JAAA Stent Graft System
- ClinicalTrials.gov ID
- NCT04745546
- Acronym / sponsor ID
- WeFlow-JAAA V1.0
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 9 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.
This study is the First in Man Study of WeFlow-JAAA Stent Graft System manufactured by EndoNom Medtech(Hangzhou) Co., Ltd.
Detailed description
This clinical trial was conducted in a qualified clinical trial institution. Investigators will use WeFlow-JAAA Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. to treat patients with juxta renal abdominal aortic aneurysms. This is a Prospective, single-center, first in man study to evaluate the safety and effectiveness of abdominal aorta stent graft system in the treatment of patients with juxta renal abdominal aortic aneurysms. Follow-up will be conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WeFlow-JAAA Stent Graft System | Experimental | Device: WeFlow-JAAA Stent Graft SystemParticipants will be treated with WeFlow-JAAA 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 (1 listed)
- 1.18 to 80 years old； 2.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; 3.Diagnosed as a perirenal abdominal aortic aneurysm, and need to reconstruct the superior mesenteric artery and both renal arteries blood supply； 4.The diameter of the proximal anchoring area (abdominal aorta at the lower edge of the superior mesenteric artery opening) is 18-34mm； 5.The upper edge of the aneurysmal body is more than 5mm from the lower edge of the superior mesenteric artery opening； 6.The distance between the bifurcation of the renal artery and the opening of the renal artery is more than 15mm, and the diameter range of the beginning of the renal artery is 5-8mm； 7.The twist angle of the proximal tumor neck (the angle between the long axis of the normal abdominal aorta and the long axis of the tumor neck) ≥120°； 8.With proper femoral artery, iliac artery, and brachial artery approach, aortic endovascular treatment can be performed.
Key exclusion criteria (14 listed)
- Severe stenosis, calcification and mural thrombosis in the proximal anchoring area；
- Pregnant, breastfeeding or cannot contraception during the trial period;
- The patient has participated in clinical trials of other drugs or devices during the same period；
- Need to intervene in other vascular diseases (such as coronary artery and carotid artery) during the same operation and the postoperative drug treatment plan is affected；
- Have history of aortic surgery or endovascular repair surgery；
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-JAAA Stent Graft SystemThe abdominal aorta stent graft system consists of the abdominal aorta embedded stent system, the abdominal aorta bifurcation stent system and the extended stent system. The abdominal aorta embedded stent has two embedded branch stents and two fenestrations. It can be combined with a peripheral small stent system of appropriate specifications to reconstruct the superior mesenteric artery, bilateral renal arteries and keep the abdominal trunk unobstructed. At the same time, the combination of the abdominal aorta embedded stent, the abdominal aorta bifurcation stent and the extended stent can solve the proximal renal and transrenal abdominal aortic aneurysm lesions with the upper edge of the abdominal aortic aneurysm body and the lower edge of the superior mesenteric artery opening ≥ 5 mm. | Device | WeFlow-JAAA Stent Graft System |
Primary outcome
Primary safety endpoint
Time frame: 30 days
No major adverse events related to device or surgery within 30 days after surgery : Major adverse events within 30 days after surgery are all-cause death, myocardial infarction, renal failure, respiratory failure, ischemic stroke, intestinal necrosis, severe ischemia, or necrosis of lower limbs.
Primary effective endpoint
Time frame: 12 months
Treatment success rate of abdominal aortic aneurysm 12 months after operation.
2 secondary outcomes
Secondary safety endpoint
Time frame: 30 days, 6 months, 12 months
Secondary effective endpoint
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 21 Feb 2021.
- Derived from this study: PubMed 37997684Gao JP, Zhang HP, Xiong J, Jia X, Ma XH, Wang LJ, Xu YL, Zhang MH, Guo W. First-in-Human Clinical Trial of the WeFlow-JAAA Endograft System in Patients With Juxtarenal Abdominal Aortic Aneurysms. J Endovasc Ther. 2025 Oct;32(5):1526-1537. doi: 10.1177/15266028231210480. Epub 2023 Nov 24.
- Individual participant dataSharing planned: No
Related trials for Juxta Renal Abdominal Aortic Aneurysm Without Rupture
Recruiting
Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms
Juxta Renal Abdominal Aortic Aneurysm Without Rupture, Complex Aortic Aneurysms
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.
Jiang Cao contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeFlow-JAAA Stent Graft System in people with Juxta Renal Abdominal Aortic Aneurysm Without Rupture, run by Hangzhou Endonom Medtech Co., Ltd. at 1 site 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 1 inclusion and 14 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Wei Guo, Professor (+861066937166, Pla301dml@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT04745546, 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 21 Feb 2021.