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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-28

Study Completion Date

2022-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05179967

Juxtarenal Abdominal Aortic Aneurysm

UNKNOWN NA

Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.

NCT05803564

Thoracoabdominal; Aortic, Aneurysm, Dissecting

RECRUITING NA

Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.

NCT05054985

Thoracoabdominal Aortic Aneurysms

RECRUITING NA

Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)

NCT07141251

Thoracoabdominal Aortic Aneurysm Endovascular Repair Complex Aortic Aneurysms

RECRUITING PHASE1

Endovascular Repair of Abdominal Aortic Aneurysms

NCT00803075

Aortic Aneurysm, Abdominal

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Juxta Renal Abdominal Aortic Aneurysm Without Rupture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WeFlow-JAAA Stent Graft System

Participants will be treated with WeFlow-JAAA Stent Graft System

Group Type EXPERIMENTAL

WeFlow-JAAA Stent Graft System

Intervention Type DEVICE

The abdominal aorta stent graft system consists of the abdominal aorta embedded stent system, the abdominal aorta bifurcation stent system and the extended stent system. The abdominal aorta embedded stent has two embedded branch stents and two fenestrations. It can be combined with a peripheral small stent system of appropriate specifications to reconstruct the superior mesenteric artery, bilateral renal arteries and keep the abdominal trunk unobstructed. At the same time, the combination of the abdominal aorta embedded stent, the abdominal aorta bifurcation stent and the extended stent can solve the proximal renal and transrenal abdominal aortic aneurysm lesions with the upper edge of the abdominal aortic aneurysm body and the lower edge of the superior mesenteric artery opening ≥ 5 mm.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WeFlow-JAAA Stent Graft System

The abdominal aorta stent graft system consists of the abdominal aorta embedded stent system, the abdominal aorta bifurcation stent system and the extended stent system. The abdominal aorta embedded stent has two embedded branch stents and two fenestrations. It can be combined with a peripheral small stent system of appropriate specifications to reconstruct the superior mesenteric artery, bilateral renal arteries and keep the abdominal trunk unobstructed. At the same time, the combination of the abdominal aorta embedded stent, the abdominal aorta bifurcation stent and the extended stent can solve the proximal renal and transrenal abdominal aortic aneurysm lesions with the upper edge of the abdominal aortic aneurysm body and the lower edge of the superior mesenteric artery opening ≥ 5 mm.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1.18 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； 6.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

1. Severe stenosis, calcification and mural thrombosis in the proximal anchoring area；
2. Pregnant, breastfeeding or cannot contraception during the trial period;
3. The patient has participated in clinical trials of other drugs or devices during the same period；
4. 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；
5. Have history of aortic surgery or endovascular repair surgery；
6. Allergic to contrast agents, anesthetics, stents and delivery materials；
7. Cannot tolerate anesthesia；
8. Severe liver, kidney, lung, and heart function abnormalities before surgery \[Serum creatinine exceeds 2 times the upper limit of normal; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal ;Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination\]；
9. Ruptured abdominal aortic aneurysm, pseudo aortic aneurysm and dissecting aortic aneurysm；
10. History of myocardial infarction, TIA or cerebral infarction within the past 3 months；
11. Contraindications in the treatment of antiplatelet agents and anticoagulants；
12. Life expectancy is less than 12 months (such as advanced malignant tumors)
13. Acute systemic infection
14. Investigator judged that not suitable for interventional treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No