CompletedNot Applicable

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

China8 participantsStarted 2019-02-28

Plain-language summary

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

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

Rate of no major adverse events related to device or surgery

Timeframe: 30 days after surgery

NCT IDNCT04764370

SponsorHangzhou Endonom Medtech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-22

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.