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

Aortic Arch; Aneurysm, Dissecting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764370
• Other study ID #: WeFlow-Arch V1.0
• Status: Completed
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: October 22, 2022

Study information

• Verified date: April 2024
• Source: Hangzhou Endonom Medtech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 22, 2022
• Est. primary completion date: October 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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?

Related Conditions & MeSH terms

• Aneurysm
• Aortic Arch; Aneurysm, Dissecting
• Aortic Dissection

Intervention

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Endonom Medtech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	immediately after the surgery
Secondary	Immediate surgery success rate	Successful delivery of the stent graft, no major adverse events related to devices or surgery.	immediately after the surgery
Secondary	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.	12 months after the surgery
Secondary	The incidence rate of secondary operations within 12 months after surgery	The incidence rate of secondary operations within 12 months after surgery.	12 months after surgery
Secondary	Adverse event rate within 12 months after surgery	Adverse event rate within 12 months after surgery.	12 months after surgery