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

Not Applicable

• Conditions: Juxta Renal Abdominal Aortic Aneurysm Without Rupture
• Interventions: Device: WeFlow-JAAA Stent Graft System

• Registration Number: NCT04745546
• Lead Sponsor: Hangzhou Endonom Medtech Co., Ltd.

Brief Summary

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 Timeline

• Study Start: 2019-10-28
• Status Verified: 2021-02
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-09
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-21
• Primary Completion: 2022-01-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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.

Exclusion Criteria

1. Severe stenosis, calcification and mural thrombosis in the proximal anchoring area；
2. Pregnant, breastfeeding or cannot contraception during the trial period;
3. The patient has participated in clinical trials of other drugs or devices during the same period；
4. 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；
5. Have history of aortic surgery or endovascular repair surgery；
6. Allergic to contrast agents, anesthetics, stents and delivery materials；
7. Cannot tolerate anesthesia；
8. 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]；
9. Ruptured abdominal aortic aneurysm, pseudo aortic aneurysm and dissecting aortic aneurysm；
10. History of myocardial infarction, TIA or cerebral infarction within the past 3 months；
11. Contraindications in the treatment of antiplatelet agents and anticoagulants；
12. Life expectancy is less than 12 months (such as advanced malignant tumors)
13. Acute systemic infection
14. Investigator judged that not suitable for interventional treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WeFlow-JAAA Stent Graft System	WeFlow-JAAA Stent Graft System	Participants will be treated with WeFlow-JAAA Stent Graft System

Primary Outcome Measures

Name	Time	Method
Primary effective endpoint	12 months	Treatment success rate of abdominal aortic aneurysm 12 months after operation.
Primary safety endpoint	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.

Secondary Outcome Measures

Name	Time	Method
Secondary safety endpoint	30 days, 6 months, 12 months	All-cause mortality, abdominal aortic aneurysm-related mortality, serious adverse events, device-related adverse events: 1. All-cause mortality 30 days, 6 months, 12 months after operation.; 2. Abdominal aortic aneurysm related mortality 30 days, 6 months, 12 months after operation.; 3. The incidence of serious adverse events 30 days, 6 months, 12 months after operation.; 4. The incidence of device-related adverse events 30 days, 6 months, 12 months after operation.
Secondary effective endpoint	30 days, 6 months, 12 months	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.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China