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

Sponsor
Hangzhou Endonom Medtech Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04764370
Collaborator
(none)
15
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Study Details

Study Description

Brief Summary

This study is the first in man study of WeFlow-Arch Module Embedded Aorta Arch Stent Graft System

Condition or Disease Intervention/Treatment Phase
  • Device: WeFlow-Ach Moduler Embedded Branch Stent Graft System
N/A

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 15 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System
Actual Study Start Date :
Feb 28, 2019
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: WeFlow-Arch Moduler Embedded Branch Stent Graft System

Device: WeFlow-Ach Moduler Embedded Branch Stent Graft System
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.

Outcome Measures

Primary Outcome Measures

  1. Rate of no major adverse events related to device or surgery [30 days after 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

  1. Technical success rate [immediately after the surgery]

    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.

  2. Immediate surgery success rate [immediately after the surgery]

    Successful delivery of the stent graft, no major adverse events related to devices or surgery.

  3. The clinical success rate [12 months after the surgery]

    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.

  4. The incidence rate of secondary operations within 12 months after surgery [12 months after surgery]

    The incidence rate of secondary operations within 12 months after surgery.

  5. Adverse event rate within 12 months after surgery [12 months after surgery]

    Adverse event rate within 12 months after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients aged 18 to 80 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。

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese PLA General Hospital Beijing China

Sponsors and Collaborators

  • Hangzhou Endonom Medtech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hangzhou Endonom Medtech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04764370
Other Study ID Numbers:
  • WeFlow-Arch V1.0
First Posted:
Feb 21, 2021
Last Update Posted:
Nov 8, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hangzhou Endonom Medtech Co., Ltd.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2021