search
Back to results

Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System

Primary Purpose

Aortic Arch; Aneurysm, Dissecting

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WeFlow-Ach Moduler Embedded Branch 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 Aortic Arch; Aneurysm, Dissecting focused on measuring Aortic Arch, Aneurysm, Dissecting, Ulcers

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged 18 to 85 years old；
  2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, dissection and ulcers involving the aortic arch;
  3. The length of the ascending aorta is greater than 4cm (from the junction of the aortic sinus tube to the proximal edge of the innominate artery)；
  4. Ascending aorta diameter ≥24mm and ≤44mm；
  5. The diameter of the iliac artery ≥7mm ；
  6. The diameter of the innominate artery ≤24mm, and the length ≥20mm；
  7. Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.

Exclusion Criteria:

  1. Patients with ascending aortic aneurysm, dissection, ulcer, hematoma；
  2. Experienced systemic infection during past three months;
  3. History of aortic valve repair or replacement；
  4. History of aortic surgery or endovascular repair surgery；
  5. Carotid artery is severely narrowed, calcified, clotted, twisted；
  6. Right axillary artery is severely narrowed, calcified, thrombosis, twisted；
  7. Heart transplant；
  8. Suffered MI or stroke during past three months；
  9. Class IV heart function (NYHA classification)；
  10. Pregnant or breastfeeding；
  11. Allergies to contrast agents；
  12. Life expectancy less than 12 months。

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WeFlow-Arch Moduler Embedded Branch Stent Graft System

Arm Description

Outcomes

Primary Outcome Measures

Rate of no major adverse events related to device or surgery
Major adverse events related to device or surgery include: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, stent bend, stent displacement, thrombosis or rupture of the approach vessel, switch to open surgery, death, etc.

Secondary Outcome Measures

Technical success rate
Successful delivery of the stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body.
Immediate surgery success rate
Successful delivery of the stent graft, no major adverse events related to devices or surgery.
The clinical success rate
Clinical success rate：12 months after the operation, there was no displacement of the stent, I and III endoleak requiring treatment, aneurysm enlargement or rupture, and branch stent occlusion.
The incidence rate of secondary operations within 12 months after surgery
The incidence rate of secondary operations within 12 months after surgery.
Adverse event rate within 12 months after surgery
Adverse event rate within 12 months after surgery.

Full Information

First Posted
February 4, 2021
Last Updated
July 19, 2023
Sponsor
Hangzhou Endonom Medtech Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04764370
Brief Title
Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System
Official Title
Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 15, 2028 (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-Arch Module Embedded Aorta Arch Stent Graft System
Detailed Description
The WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System first in man study is a prospective, single center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System in the treatment of patients with lesions of the aortic arch.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Arch; Aneurysm, Dissecting
Keywords
Aortic Arch, Aneurysm, Dissecting, Ulcers

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
WeFlow-Arch Moduler Embedded Branch Stent Graft System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
WeFlow-Ach Moduler Embedded Branch Stent Graft System
Intervention Description
The modular embedded aortic arch stent graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system and the branch stent system.
Primary Outcome Measure Information:
Title
Rate of no major adverse events related to device or surgery
Description
Major adverse events related to device or surgery include: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, stent bend, stent displacement, thrombosis or rupture of the approach vessel, switch to open surgery, death, etc.
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Technical success rate
Description
Successful delivery of the stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body.
Time Frame
immediately after the surgery
Title
Immediate surgery success rate
Description
Successful delivery of the stent graft, no major adverse events related to devices or surgery.
Time Frame
immediately after the surgery
Title
The clinical success rate
Description
Clinical success rate：12 months after the operation, there was no displacement of the stent, I and III endoleak requiring treatment, aneurysm enlargement or rupture, and branch stent occlusion.
Time Frame
12 months after the surgery
Title
The incidence rate of secondary operations within 12 months after surgery
Description
The incidence rate of secondary operations within 12 months after surgery.
Time Frame
12 months after surgery
Title
Adverse event rate within 12 months after surgery
Description
Adverse event rate within 12 months after surgery.
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18 to 85 years old； Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, dissection and ulcers involving the aortic arch; The length of the ascending aorta is greater than 4cm (from the junction of the aortic sinus tube to the proximal edge of the innominate artery)； Ascending aorta diameter ≥24mm and ≤44mm； The diameter of the iliac artery ≥7mm ； The diameter of the innominate artery ≤24mm, and the length ≥20mm； Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol. Exclusion Criteria: Patients with ascending aortic aneurysm, dissection, ulcer, hematoma； Experienced systemic infection during past three months; History of aortic valve repair or replacement； History of aortic surgery or endovascular repair surgery； Carotid artery is severely narrowed, calcified, clotted, twisted； Right axillary artery is severely narrowed, calcified, thrombosis, twisted； Heart transplant； Suffered MI or stroke during past three months； Class IV heart function (NYHA classification)； Pregnant or breastfeeding； Allergies to contrast agents； Life expectancy less than 12 months。
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System

We'll reach out to this number within 24 hrs