Guo's Visceral Arteries Reconstruction :The First in Man Study of WeFlow-JAAA Stent Graft System

NCT04745546 | Unknown

• 1 other identifier: WeFlow-JAAA V1.0
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the First in Man Study of WeFlow-JAAA Stent Graft System manufactured by EndoNom Medtech(Hangzhou) Co., Ltd.

Conditions

Juxta Renal Abdominal Aortic Aneurysm Without Rupture

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days

• Primary effective endpoint

  Treatment success rate of abdominal aortic aneurysm 12 months after operation.

  12 months

Secondary Outcomes (2)

• Secondary safety endpoint

  30 days, 6 months, 12 months

• Secondary effective endpoint

  30 days, 6 months, 12 months

Study Arms (1)

WeFlow-JAAA Stent Graft System

EXPERIMENTAL

Participants will be treated with WeFlow-JAAA Stent Graft System

Device: WeFlow-JAAA Stent Graft System

Interventions

WeFlow-JAAA Stent Graft System DEVICE

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.

WeFlow-JAAA Stent Graft System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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；
• 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.

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37997684 DERIVED

Central Study Contacts

Wei Guo, Professor

CONTACT

+861066937166; Pla301dml@vip.sina.com

Jiang Cao

CONTACT

+861066937166

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: October 28, 2019
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)