Status:
COMPLETED
Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System
Lead Sponsor:
Hangzhou Endonom Medtech Co., Ltd.
Conditions:
Aortic Arch; Aneurysm, Dissecting
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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。
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04764370
Start Date
February 28 2019
End Date
October 22 2022
Last Update
April 30 2024
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, China