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

Hangzhou Endonom Medtech

Status: Completed

Conditions: Aortic Arch; Aneurysm, Dissecting

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04764370

WeFlow-Arch V1.0

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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。

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

WeFlow-Arch Moduler Embedded Branch Stent Graft System

Experimental group

Treatment:

Device: WeFlow-Ach Moduler Embedded Branch Stent Graft System