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

February 19, 2021 updated by: Hangzhou Endonom Medtech Co., Ltd.

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

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

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jiang Cao
  • Phone Number: +861066937166

Study Locations

      • Beijing, China
        • Recruiting
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

1.18 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WeFlow-JAAA Stent Graft System
Participants will be treated with 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary safety endpoint
Time Frame: 30 days

No major adverse events related to device or surgery within 30 days after surgery :

Major adverse events within 30 days after surgery are all-cause death, myocardial infarction, renal failure, respiratory failure, ischemic stroke, intestinal necrosis, severe ischemia, or necrosis of lower limbs.

30 days
Primary effective endpoint
Time Frame: 12 months
Treatment success rate of abdominal aortic aneurysm 12 months after operation.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary safety endpoint
Time Frame: 30 days, 6 months, 12 months

All-cause mortality, abdominal aortic aneurysm-related mortality, serious adverse events, device-related adverse events:

  1. All-cause mortality 30 days, 6 months, 12 months after operation.
  2. Abdominal aortic aneurysm related mortality 30 days, 6 months, 12 months after operation.
  3. The incidence of serious adverse events 30 days, 6 months, 12 months after operation.
  4. The incidence of device-related adverse events 30 days, 6 months, 12 months after operation.
30 days, 6 months, 12 months
Secondary effective endpoint
Time Frame: 30 days, 6 months, 12 months
The incidence of type I or type III endoleak, the incidence of stent graft displacement, the patency rate of branch vessels, the incidence of conversion to open surgery or secondary interventional surgery.
30 days, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2019

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Juxta Renal Abdominal Aortic Aneurysm Without Rupture

Clinical Trials on WeFlow-JAAA Stent Graft System

3
Subscribe