Clinical trial NCT05179967: Safety and Efficacy Study of WeFlow-JAAA Stent Graft System for Complex Abdominal Aortic Aneurysm(GREAT Study)
Official title: Guo's visceRal artEries Reconstruction :The Prospective, Multiple Center, Objective Performance Criteria Clinical Trial About the sAfTy and Efficacy of WeFlow-JAAATM Stent Graft System.(GREAT Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Juxtarenal Abdominal Aortic Aneurysm
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-06
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of WeFlow-JAAA stent graft system manufactured by Hangzhou Endonom Medtech Co., Ltd. for the complex abdominal aortic aneurysm.


Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years old, regardless of gender;
2. Subjects who were diagnosed with Juxtarenal and Pararenal abdominal aortic aneurysms and needed to reconstruct the blood supply of superior mesenteric artery and bilateral renal arteries;
3. Have appropriate vascular conditions, mainly including:

   * The distance between the upper edge of the aneurysm and the lower edge of the opening of superior mesenteric artery ≥ 4mm;
   * The angle between the proximal aneurysm neck and the aortic long axis near the opening of superior mesenteric artery ≤ 60 ° ;
   * The aortic diameter at the opening of superior mesenteric artery ranges from 18 to 34 mm ；
   * The diameter range of the starting part of superior mesenteric artery is 5-12mm；
   * The diameter range of the initial part of bilateral renal arteries is 4.5-10mm;
   * Length of non bifurcated segment of superior mesenteric artery and renal artery ≥ 10mm;
   * Blood vessel diameter at the bifurcation of abdominal aorta ≥ 16mm；
   * The length of distal anchoring area of iliac artery ≥ 15mm;
   * The diameter range of distal anchoring area of iliac artery is 8-24mm;
   * With appropriate femoral artery、iliac artery and upper limb artery approaches, endovascular treatment can be performed.
4. Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements.

Exclusion Criteria:

1. Patients with ruptured abdominal aortic aneurysm, pseudoaortic aneurysm and dissecting aortic aneurysm with hemodynamic instability;
2. Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases);
3. Severe stenosis, calcification and mural thrombosis in the proximal anchoring area of the stent;
4. Other vascular diseases need to be intervened in the same operation (such as coronary artery and carotid artery) and the postoperative drug treatment scheme is affected;
5. There is a history of myocardial infarction, TIA or cerebral infarction in recent 3 months;
6. The subject has a history of abdominal aortic surgery or endovascular repair;
7. Patients with severe liver, kidney, lung and cardiac dysfunction before operation \[subjects with serum creatinine level \> 150umol / L; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper normal limit; total serum bilirubin (STB) subjects who exceed 2 times the upper limit of normal; subjects whose left ventricular ejection fraction is less than 50% by color Doppler echocardiography.\];
8. Patients with acute systemic infection;
9. Patients with contraindications to antiplatelet agents and anticoagulants;
10. Subjects are allergic to contrast agents, anesthetics, stents and conveyor materials;
11. Subjects cannot tolerate anesthesia;
12. Subjects Women who are pregnant or lactating or who cannot use contraception during the trial;
13. Subjects whose life expectancy is less than 12 months (such as advanced malignant tumor);
14. Subjects have participated in clinical trials of other drugs or devices in the same period;
15. The researchers determine that the subjects' vascular conditions affect the revascularization of branch arteries or are combined with other diseases and are not suitable to participate in this study.

Primary outcomes:
measure: Rate of no major adverse events occurred within 30 days after operation
timeFrame: Within 30th day after operation
measure: The success rate of treatment of abdominal aortic aneurysm 12 months after operation
timeFrame: 12 months after operation
Secondary outcomes:
measure: Rate of all cause mortality
timeFrame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
measure: Rate of abdominal aortic aneurysm related mortality
timeFrame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
measure: Incidence of serious adverse events
timeFrame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
measure: Incidence of device related adverse events
timeFrame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
measure: Incidence of type I or type III internal leakage
timeFrame: Intraoperative, before discharge, 6 months, 12 months
measure: Incidence of aortic covered stent displacement
timeFrame: 6 and 12 months after operation
measure: Patency rate of postoperative branches
timeFrame: Before discharge, 6 months, 12 months
measure: Incidence of conversion to open surgery or secondary interventional surgery for abdominal aortic aneurysm
timeFrame: Before discharge, 6 months, 12 months, 2 ~ 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army
Study officials:
References: