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

NCT04764370 | Completed

• 1 other identifier: WeFlow-Arch V1.0
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Arch; Aneurysm, Dissecting

Keywords

Aortic Arch; Aneurysm; Dissecting; Ulcers

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days after surgery

Secondary Outcomes (5)

• Technical success rate

  immediately after the surgery

• Immediate surgery success rate

  immediately after the surgery

• The clinical success rate

  12 months after the surgery

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

  12 months after surgery

• Adverse event rate within 12 months after surgery

  12 months after surgery

Study Arms (1)

WeFlow-Arch Moduler Embedded Branch Stent Graft System

EXPERIMENTAL

Device: WeFlow-Ach Moduler Embedded Branch Stent Graft System

Interventions

WeFlow-Ach Moduler Embedded Branch Stent Graft System DEVICE

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.

WeFlow-Arch Moduler Embedded Branch Stent Graft System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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。

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Aneurysm; Ulcer

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 21, 2021
• Study Start: February 28, 2019
• Primary Completion: October 22, 2022
• Study Completion: October 22, 2022
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)