Safety and Efficacy Study of WeFlow-JAAA Stent Graft System for Complex Abdominal Aortic Aneurysm(GREAT Study)

NCT05179967 | Unknown

• 1 other identifier: WEIQIANG202101
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Juxtarenal Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Rate of no major adverse events occurred within 30 days after operation

  The main adverse events within 30 days after operation refer to all-cause death, myocardial infarction, renal failure, respiratory failure, ischemic stroke, intestinal necrosis, severe ischemia or necrosis of lower limbs and paraplegia within 30 days after operation. Among them, renal failure leads to lasting dialysis, renal transplantation or other fatal results. Respiratory failure leads to significantly prolonged intubation time, tracheotomy, deterioration of pulmonary function or other fatal results. Intestinal necrosis refers to intestinal ischemia that requires intestinal resection or leads to other fatal results. Severe ischemia of lower limbs refers to new severe claudication or resting pain after operation.

  Within 30th day after operation

• The success rate of treatment of abdominal aortic aneurysm 12 months after operation

  Immediate postoperative technical success refers to the successful delivery of the conveyor of aortic and branch covered stents to the predetermined position, the accurate positioning and successful deployment of the stent, and the conveyor can be safely withdrawn from the body. At the end of the operation, there is no type I and III internal leakage and the branch stent is unobstructed.

  12 months after operation

Secondary Outcomes (8)

• Rate of all cause mortality

  Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation

• Rate of abdominal aortic aneurysm related mortality

  Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation

• Incidence of serious adverse events

  Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation

• Incidence of device related adverse events

  Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation

• Incidence of type I or type III internal leakage

  Intraoperative, before discharge, 6 months, 12 months

Study Arms (1)

WeFlow-JAAA Stent Graft System

EXPERIMENTAL

Device: WeFlow-JAAA Stent Graft System

Interventions

WeFlow-JAAA Stent Graft System DEVICE

WeFlow-JAAA Stent Graft System consists of abdominal main body of inner embedded stent graft , abdominal main bifurcation stent graft, extension stent graft and branch stent graft. The abdominal main body of inner embedded stent graft is composed of abdominal main embedded covered stent and conveyor, the abdominal main bifurcated stent graft is composed of abdominal main bifurcated stent and conveyor, the extended stent is composed of extended stent graft and conveyor, and the branch vascular stent graft is composed of branch vascular stent and conveyor. The abdominal main body of inner embedded stent graft, abdominal main bifurcation stent graft, extension stent graft and branch vascular stent graft are pre-installed in the corresponding conveyor respectively.

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:

• 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:
• 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.
• 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.

You may not qualify if:

• Patients with ruptured abdominal aortic aneurysm, pseudoaortic aneurysm and dissecting aortic aneurysm with hemodynamic instability;
• Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases);
• 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 \[subjects with serum creatinine level \> 150umol / L; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper normal limit; total serum bilirubin (STB) subjects who exceed 2 times the upper limit of normal; subjects whose left ventricular ejection fraction is less than 50% by color Doppler echocardiography.\];
• Patients with acute systemic infection;
• Patients with contraindications to antiplatelet agents and anticoagulants;
• Subjects are allergic to contrast agents, anesthetics, stents and conveyor materials;
• Subjects cannot tolerate anesthesia;
• Subjects Women who are pregnant or lactating or who cannot use contraception during the trial;
• Subjects whose life expectancy is less than 12 months (such as advanced malignant tumor);
• Subjects have participated in clinical trials of other drugs or devices in the same period;
• 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.

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Study Sites (1)

The General Hospital of the People's Liberation Army

Beijing, China

RECRUITING

Central Study Contacts

Wei Guo, Chief doctor

CONTACT

13910758706; Pla301dml@vip.sina.com

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: December 17, 2021
• First Posted: January 6, 2022
• Study Start: February 23, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

CN (1)