Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)

Aortic Arch Aneurysm Clinical Trial

Official title:

Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch Unique Embedded Aortic Triple-branch Arch Stent Graft System (GENIUS Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06385379
• Other study ID #: WQ21-2301
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: Hangzhou Endonom Medtech Co., Ltd.
• Contact: Wei Guo
• Phone: 13910758706
• Email: Pla301dml[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)

Description:

This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System , it is expected to complete the implantation of 90 patients in 20 centers within 20 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 24th month, 36th month, 48th month and 60th month postoperatively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

• Branch arteries to be reconstructed were = 24 mm and = 6 mm in diameter and = 20 mm in length;

• 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. Subjects were assessed as high risk for surgery by at least two investigators or judged to have significant surgical contraindications. Recommended reference criteria were a European system for cardiac operative risk evaluation (EuroScore) score of 6 or higher or other surgical risk factors as judged by the physician team.

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 branch artery to be reconstructed;

6. Heart transplant;

7. Suffered Myocardial Infarction 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), Coagulation disorders, thrombocytopenia (PLT count < 50 × 109/L);

11. Renal insufficiency, creatinine > 150 umol/L and/or end-stage renal disease requiring renal dialysis;

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Arch Aneurysm

Intervention

Device:
• WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
The WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system, the aortic extension stent graft system and the branch stent system.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing
China	Chinese PLA Gencral Hosptial	Beijing
China	The First Hospital of Jilin University	Changchun
China	Xiangya Hospital of Central South University	Changsha
China	West China Hospital of Sichuan University	Chengdu
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou
China	The First Affiliated Hospital ,Sun Yat-sen University	Guangzhou
China	The First Affiliated Hospital of Harbin Medical University	Harbin
China	Shandong Provincial Hospital	Jinan
China	The First People's Hospital of Yunnan Province	Kunming
China	The Second Affiliated Hospital Of Nanchang University	Nanchang
China	Nanjing First Hospital	Nanjing
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing
China	The Affiliated Hospital Of Qingdao University	Qingdao
China	Shanghai Chest Hospital	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai
China	The First Affiliated Hospital of China Medical University	Shenyang
China	Xiamen Cardiovascular Hospital	Xiamen
China	The First Affiliated Hospital of PLA Air Force Military Medical University	Xian
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Endonom Medtech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months after surgery
Secondary	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 and all branching stents patency per imaging studies conducted at the end of the procedure .	immediately after the surgery
Secondary	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.	12 months after operation
Secondary	Incidence of Type I or Type III endoleak	Endoleak detected by DSA or CTA during operation and at 1, 6, and 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.	during operation and at 1, 6, and 12 months after operation
Secondary	Incidence of aortic covered stent graft displacement	CTA examination will be performed at 6 months, and 12 months after 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 compared with that at postoperative day 30.	6 months, 12 months after operation
Secondary	Postoperative branch vessel patency rate	CTA examinations will be performed at 1 month, 6 months, and 12 months after operation to evaluate branch vessel reconstruction and assess for occlusion, stenosis, or in-stent thrombosis.	1 month, 6 months, 12 months after operation
Secondary	Rate of conversion to thoracotomy or secondary intervention	Whether or not the patient experienced surgically induced de novo aortic dissection converted to thoracotomy or secondary intervention will be determined.	30 days, 6 months, and 12 months after operation
Secondary	Rate of major adverse events	Refers to all-cause mortality, myocardial infarction, ischemic stroke, or respiratory failure occurring within 30 days after surgery.; More specifically, myocardial infarction refers to a drastic reduction or complete interruption of the coronary blood supply due to coronary artery disease, resulting in severe and prolonged acute ischemia of the corresponding myocardium, leading to necrosis of cardiomyocytes.; Ischemic stroke refers to the result of necrosis of brain tissue caused by narrowing or occlusion of the arteries supplying blood to the brain or insufficient blood supply to the brain.; Respiratory failure is defined as a state resulting in significantly prolonged intubation, tracheotomy, deterioration of lung function, or other fatal outcomes.	30 days after surgery
Secondary	Rate of aortic aneurysm-related mortality	Death due to aortic aneurysm rupture or endovascular treatment.	12 months after operation
Secondary	Incidence of severe adverse events	Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid permanent defects in body structure or body function.	30 days, 6 months, and 12 months after operation
Secondary	Incidence of device-related adverse events	Device-related adverse events refer to an adverse medical event related to the use of a device that occurs during the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event. Recording of device-related adverse events will be applicable for conditions that are deemed by the investigator to be definitely related, possibly related to the test device.	30 days, 6 months, and 12 months after operation