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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Arch; Aneurysm, Dissecting
• Intervention / Treatment: Device: WeFlow-Ach Moduler Embedded Branch 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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。

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WeFlow-Arch Moduler Embedded Branch Stent Graft System	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of no major adverse events related to device or surgery	Major adverse events related to device or surgery include: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, stent bend, stent displacement, thrombosis or rupture of the approach vessel, switch to open surgery, death, etc.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	Successful delivery of the stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body.	immediately after the surgery
Immediate surgery success rate	Successful delivery of the stent graft, no major adverse events related to devices or surgery.	immediately after the surgery
The clinical success rate	Clinical success rate：12 months after the operation, there was no displacement of the stent, I and III endoleak requiring treatment, aneurysm enlargement or rupture, and branch stent occlusion.	12 months after the surgery
The incidence rate of secondary operations within 12 months after surgery	The incidence rate of secondary operations within 12 months after surgery.	12 months after surgery
Adverse event rate within 12 months after surgery	Adverse event rate within 12 months after surgery.	12 months after surgery

Collaborators and Investigators

• Sponsor: Hangzhou Endonom Medtech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Estimated): January 15, 2024
• Study Completion (Estimated): January 15, 2028

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Aneurysm; Ulcers; Aortic Arch; Dissecting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aneurysm; Aortic Dissection
• Other Study ID Numbers: WeFlow-Arch V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No