Safety and Efficacy Study of WeFlow-JAAA Stent Graft System for Complex Abdominal Aortic Aneurysm… (NCT05179967) | Clinical Trial Compass
UnknownNot Applicable
Safety and Efficacy Study of WeFlow-JAAA Stent Graft System for Complex Abdominal Aortic Aneurysm(GREAT Study)
China106 participantsStarted 2022-02-23
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 18-80 years old, regardless of gender;
✓. 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;
✓. Have appropriate vascular conditions, mainly including:
✓. 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
✕. Patients with ruptured abdominal aortic aneurysm, pseudoaortic aneurysm and dissecting aortic aneurysm with hemodynamic instability;
✕. Severe stenosis, calcification and mural thrombosis in the proximal anchoring area of the stent;
✕. 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;
✕. There is a history of myocardial infarction, TIA or cerebral infarction in recent 3 months;
✕. The subject has a history of abdominal aortic surgery or endovascular repair;
✕. Patients with severe liver, kidney, lung and cardiac dysfunction before operation \[subjects with serum creatinine level \> 150umol / L; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper normal limit; total serum bilirubin (STB) subjects who exceed 2 times the upper limit of normal; subjects whose left ventricular ejection fraction is less than 50% by color Doppler echocardiography.\];
What they're measuring
1
Rate of no major adverse events occurred within 30 days after operation
Timeframe: Within 30th day after operation
2
The success rate of treatment of abdominal aortic aneurysm 12 months after operation