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

  • STATUS
    Recruiting
  • days left to enroll
    64
  • participants needed
    15
  • sponsor
    Hangzhou Endonom Medtech Co., Ltd.
Updated on 5 March 2021

Summary

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

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.

Details
Condition Juxta Renal Abdominal Aortic Aneurysm Without Rupture
Treatment WeFlow-JAAA Stent Graft System
Clinical Study IdentifierNCT04745546
SponsorHangzhou Endonom Medtech Co., Ltd.
Last Modified on5 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

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
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