Clinical trial NCT04764370: Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System
Official title: Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Arch; Aneurysm, Dissecting
Keywords: Aortic Arch
Aneurysm
Dissecting
Ulcers
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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。

Primary outcomes:
measure: Rate of no major adverse events related to device or surgery
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Technical success rate
timeFrame: immediately after the surgery
measure: Immediate surgery success rate
timeFrame: immediately after the surgery
measure: The clinical success rate
timeFrame: 12 months after the surgery
measure: The incidence rate of secondary operations within 12 months after surgery
timeFrame: 12 months after surgery
measure: Adverse event rate within 12 months after surgery
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References: