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

Primary Purpose

Juxta Renal Abdominal Aortic Aneurysm Without Rupture

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WeFlow-JAAA Stent Graft System
Sponsored by
Hangzhou Endonom Medtech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juxta Renal Abdominal Aortic Aneurysm Without Rupture

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WeFlow-JAAA Stent Graft System

Arm Description

Participants will be treated with WeFlow-JAAA Stent Graft System

Outcomes

Primary Outcome Measures

Primary safety endpoint
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.
Primary effective endpoint
Treatment success rate of abdominal aortic aneurysm 12 months after operation.

Secondary Outcome Measures

Secondary safety endpoint
All-cause mortality, abdominal aortic aneurysm-related mortality, serious adverse events, device-related adverse events: All-cause mortality 30 days, 6 months, 12 months after operation. Abdominal aortic aneurysm related mortality 30 days, 6 months, 12 months after operation. The incidence of serious adverse events 30 days, 6 months, 12 months after operation. The incidence of device-related adverse events 30 days, 6 months, 12 months after operation.
Secondary effective endpoint
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.

Full Information

First Posted
February 4, 2021
Last Updated
February 19, 2021
Sponsor
Hangzhou Endonom Medtech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04745546
Brief Title
Guo's Visceral Arteries Reconstruction :The First in Man Study of WeFlow-JAAA Stent Graft System
Official Title
Guo's Visceral Arteries Reconstruction: The First in Man Study of WeFlow-JAAA Stent Graft System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Endonom Medtech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juxta Renal Abdominal Aortic Aneurysm Without Rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WeFlow-JAAA Stent Graft System
Arm Type
Experimental
Arm Description
Participants will be treated with WeFlow-JAAA Stent Graft System
Intervention Type
Device
Intervention Name(s)
WeFlow-JAAA Stent Graft System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary safety endpoint
Description
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.
Time Frame
30 days
Title
Primary effective endpoint
Description
Treatment success rate of abdominal aortic aneurysm 12 months after operation.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Secondary safety endpoint
Description
All-cause mortality, abdominal aortic aneurysm-related mortality, serious adverse events, device-related adverse events: All-cause mortality 30 days, 6 months, 12 months after operation. Abdominal aortic aneurysm related mortality 30 days, 6 months, 12 months after operation. The incidence of serious adverse events 30 days, 6 months, 12 months after operation. The incidence of device-related adverse events 30 days, 6 months, 12 months after operation.
Time Frame
30 days, 6 months, 12 months
Title
Secondary effective endpoint
Description
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.
Time Frame
30 days, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Severe stenosis, calcification and mural thrombosis in the proximal anchoring area; Pregnant, breastfeeding or cannot contraception during the trial period; The patient has participated in clinical trials of other drugs or devices during the same period; 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; Have history of aortic surgery or endovascular repair surgery; Allergic to contrast agents, anesthetics, stents and delivery materials; Cannot tolerate anesthesia; 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]; Ruptured abdominal aortic aneurysm, pseudo aortic aneurysm and dissecting aortic aneurysm; History of myocardial infarction, TIA or cerebral infarction within the past 3 months; Contraindications in the treatment of antiplatelet agents and anticoagulants; Life expectancy is less than 12 months (such as advanced malignant tumors) Acute systemic infection Investigator judged that not suitable for interventional treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Guo, Professor
Phone
+861066937166
Email
Pla301dml@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Cao
Phone
+861066937166
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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