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

NCT ID: NCT04764370

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2022-10-22

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.

Conditions

Aortic Arch; Aneurysm, Dissecting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WeFlow-Arch Moduler Embedded Branch Stent Graft System

Group Type: EXPERIMENTAL

WeFlow-Ach Moduler Embedded Branch Stent Graft System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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。

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Endonom Medtech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese PLA General Hospital

Beijing, , China

Countries

China

Other Identifiers

WeFlow-Arch V1.0

Identifier Type: -

Identifier Source: org_study_id