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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Juxtarenal Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: WeFlow-JAAA Stent Graft System

• Study Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Guo, Chief doctor; Phone Number: 13910758706; Email: Pla301dml@vip.sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • The General Hospital of the People's Liberation Army

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: WeFlow-JAAA Stent Graft System

Device: WeFlow-JAAA Stent Graft System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all cause mortality	All cause death refers to death from any cause during the follow-up period	Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Rate of abdominal aortic aneurysm related mortality	Rate of abdominal aortic aneurysm related death refers to death caused by aneurysm rupture or surgery for aortic aneurysm	Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Incidence of serious adverse events	Serious adverse events refer to events that lead to death or serious deterioration of health status during clinical trials, including fatal diseases or injuries, permanent defects in body structure or function, and the need for medical or surgical intervention to avoid permanent defects in body structure or function.	Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Incidence of device related adverse events	Device related adverse events refer to adverse medical events related to the use of devices during clinical trials. However, normal postoperative stress reactions, such as fever and chest and back discomfort, should be distinguished. If they are judged as normal postoperative stress reactions by the researchers, they need not be recorded in adverse events. Recording device related adverse events refers to the situation that the investigator determines to be definitely related, possibly related or unable to determine with the test device.	Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Incidence of type I or type III internal leakage	The internal leakage shown by DSA or CTA was recorded. The internal leakage occurred during the operation and the adjuvant treatment is not recorded. Internal leakage after operation and untreated internal leakage in the same subject at different follow-up stages shall be calculated once.	Intraoperative, before discharge, 6 months, 12 months
Incidence of aortic covered stent displacement	CTA was observed and recorded 6 months and 12 months after operation to check whether the stent was displaced. The main stent and branch stent were recorded and evaluated. Displacement was defined as the displacement of aortic and branch covered stents at the postoperative follow-up node more than 10mm compared with that before discharge.	6 and 12 months after operation
Patency rate of postoperative branches	CTA was observed and recorded before discharge, 6 months and 12 months to evaluate the revascularization of branches of renal artery and superior mesenteric artery, and whether there was occlusion, stenosis or stent thrombosis. Postoperative branch vessel stenosis ≤ 50% is regarded as unobstructed.	Before discharge, 6 months, 12 months
Incidence of conversion to open surgery or secondary interventional surgery for abdominal aortic aneurysm	To evaluate whether the subjects were converted to open surgery or secondary interventional surgery due to abdominal aortic aneurysm.	Before discharge, 6 months, 12 months, 2 ~ 5 years

Collaborators and Investigators

• Sponsor: Hangzhou Endonom Medtech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: WEIQIANG202101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No