Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study)

N/AActive Not RecruitingNCT04765592

Hangzhou Endonom Medtech Co., Ltd.88 enrolled

Overview

A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/false aortic arch aneurysms and ulcers involving aortic arch . (GIANT Study)

This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System, it is expected to complete the implantation of 80 patients in 23 centers within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Arch Aneurysm

Interventions

WeFlow-Arch Modeler Embedded Branch Stent Graft SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients aged 18 to 80 years old; 2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch; 3. Showing a suitable vascular condition, including: * Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery). * Ascending aorta diameter ≥ 24 mm and ≤ 48 mm; * Proximal anchoring zone length ≥ 30 mm; * Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm； * Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm； * Suitable arterial access for endovascular interventional treatment; 4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol. 5. Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications. Exclusion Criteria: 1. Experienced systemic infection during past three months; 2. Neck surgery was performed within 3 months; 3. Previous endovascular interventional treatment involving the aortic arch was performed; 4. Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases ); 5. Severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian artery; 6. Heart transplant; 7. Suffered MI or stroke during past three months; 8. Class IV heart function (NYHA classification); 9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months; 10. Hematological abnormality, defined as follows: Leukopenia (WBC \< 3 × 109/L), acute anemia (Hb \< 90 g/L); thrombocytopenia (PLT count \< 50 × 109/L), history of bleeding or coagulopathy; 11. Renal insufficiency， creatinine \> 265 umol/L (or 3.0mg/dL) and/or end-stage renal disease requiring renal dialysis, as determined by an investigator after a thorough analysis; 12. Pregnant or breastfeeding; 13. Allergies to contrast agents; 14. Life expectancy of less than 12 months; 15. Participating in another drug or device research; 16. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.

Locations (23)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

Rate of all-cause mortality and major stroke within 12 months after surgery

All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset.

Time frame: 12 months after surgery

Secondary Outcomes

Rate of immediate technical success following surgery

Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, and the absence of Type I and III endoleaks per imaging studies conducted at the end of the procedure with all branching stents patency.

Time frame: immediately after the surgery

Rate of aortic aneurysm progression under control

Aortic aneurysm progression under control is defined as maximum increase in the diameter of the aortic aneurysm was ≤ 5 mm when compared with preoperative aortic aneurysm as of a 12-month postoperative CTA review

Time frame: 12 months after operation

Incidence of Type I or Type III endoleak

Incidence of Type I or Type III endoleak before discharge, 1 month, 6 months, 12 months after operation. Intraoperative endoleaks subject to adjuvant treatment are not recorded. Endoleaks occurring after the completion of the procedure followed by one or more endoleaks occurring in the same subject at different follow-up stages that were not treated are counted as a single instance.

Time frame: immediately after the surgery, 1 month, 6 months, 12 months after the surgery

Incidence of aortic arch stent graft displacement

CTA examination will be performed at 1 month, 6 months, and 12 months post operation to determine if the stent has migrated, and evaluations will be recorded for both the main and branch stents. Displacement is defined as a nodal aortic or branching stent graft displacement of more than 10 mm from pre-discharge levels.

Data from ClinicalTrials.gov

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