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

Not Applicable

Completed

• Conditions: Aortic Arch; Aneurysm, Dissecting
• Interventions: Device: WeFlow-Ach Moduler Embedded Branch Stent Graft System

• Registration Number: NCT04764370
• Lead Sponsor: Hangzhou Endonom Medtech Co., Ltd.

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.

Study Timeline

• Study Start: 2019-02-28
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-21
• Primary Completion: 2022-10-22
• Study Completion: 2022-10-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-28
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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。

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WeFlow-Arch Moduler Embedded Branch Stent Graft System	WeFlow-Ach Moduler Embedded Branch Stent Graft System	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Adverse event rate within 12 months after surgery	12 months after surgery	Adverse event rate within 12 months after surgery.
Immediate surgery success rate	immediately after the surgery	Successful delivery of the stent graft, no major adverse events related to devices or surgery.
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.
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.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China