Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)

Type B Aortic Dissection Clinical Trial

Official title:

Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04765605
• Other study ID #: WeFlow001
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 25, 2020
• Est. completion date: December 25, 2026

Study information

• Verified date: August 2023
• Source: Hangzhou Endonom Medtech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system manufactured by EndoNom Medtech (Hangzhou) Co., Ltd.

Description:

This study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system in the treatment of Stanford type B dissection of the proximal left subclavian artery. It is expected to complete the implantation of 120 patients in 29 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 25, 2026
• Est. primary completion date: December 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18 to 80 years old, no gender limitation;

2. 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;

3. Diagnosed as Stanford type B aortic dissection and needed reconstruction of the left subclavian artery;

4. The diameter of the proximal anchoring area (the aorta at the posterior edge of the left common carotid artery) range: 18~42mm;

5. The length of the proximal anchoring area (the distance from the rear edge of the left common carotid artery opening to the first breach) =15mm;

6. The distance between the left common carotid artery and the left subclavian artery =5mm;

7. The distance between the left vertebral artery and the opening of the left subclavian artery is =15mm, the diameter of the starting part of the left subclavian artery is 6~20mm

8. With proper femoral artery, iliac artery, and brachial artery access, endovascular treatment of the aorta can be performed.

Exclusion Criteria:

1. Pregnant, breastfeeding or cannot contraception during the trial period;

2. Participated in clinical trials of other drugs or devices during the same period;

3. The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.), and the postoperative drug treatment plan is therefore affected;

4. Allergic to contrast agents, anesthetics, patches, and delivery materials;

5. Cannot tolerate anesthesia;

6. Severe liver, kidney, lung, and heart function abnormalities before surgery [Serum creatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination];

7. True/false thoracic aortic aneurysm

8. History of myocardial infarction, TIA or cerebral infarction within the past 3 months;

9. Contraindications to antiplatelet drugs and anticoagulants

10. Life expectancy is less than 12 months (such as advanced malignant tumors)

11. Acute systemic infection

12. Severe stenosis or calcification in the anchoring area at the proximal end of the stent, easily lead to the stent graft difficult adherent

13. Investigator judged that not suitable for interventional treatment.

Related Conditions & MeSH terms

• Aortic Dissection
• Type B Aortic Dissection

Intervention

Device:
• WeFlow-Tbranch Stent Graft System
The single-embedded branch thoracic aorta stent graft system consists of the thoracic aorta stent graft system and the branch stent system. The main chest embedded stent graft system consists of the main chest embedded stent graft and its system conveyor, and the branch stent system consists of branch stents and its conveyor. The main chest embedded stent graft and the branch stent are pre-installed in the conveyor

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing
China	Fuwai Hospital, Chinese Academy of Medical Sciences	Beijing
China	Xiangya Hospital of Central South University	Changsha
China	West China Hospital of Sichuan University	Chengdu
China	Foshan First People's Hospital	Foshan
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou
China	First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Provincial People's Hospital	Hangzhou
China	Anhui Provincial Hospital	Hefei
China	Shandong Provincial Hospital	Jinan
China	The First People's Hospital of Yunnan Province	Kunming
China	Affiliated Hospital of Southwest Medical University	Luzhou
China	The Second Affiliated Hospital of Nanchang University	Nanchang
China	Jiangsu Provincial People's Hospital	Nanjing
China	Nanjing Gulou Hospital	Nanjing
China	The First Affiliated Hospital of Guangxi Medical University	Nanning
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Jiaotong University Affiliated Ninth People's Hospital	Shanghai
China	The Second Affiliated Hospital of Naval Medical University	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai
China	The First Hospital of Hebei Medical University	Shijia Zhuang
China	The First Affiliated Hospital of Soochow University	Suzhou
China	Shanxi Bethune Hospital	Taiyuan
China	Tianjin Chest Hospital	Tianjin
China	Tianjin Medical University General Hospital	Tianjin
China	The First Affiliated Hospital of PLA Air Force Military Medical University	Xian
China	Yantai Yuhuangding Hospital	Yantai
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 no major adverse events within 30 days after surgery.	Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, liver failure, renal failure, intestinal necrosis, paraplegia, and amputation within 30 days after operation. Among them, renal failure refers to long-lasting dialysis, kidney transplantation, or other fatal results. Intestinal necrosis is intestinal ischemia that requires bowel resection or other fatal consequences. Severe lower limb ischemia refers to new severe limp or resting pain after surgery.	30 days after operation
Primary	Treatment success rate of aortic dissection 12 months after operation	The success rate of aortic dissection treatment at 12 months is a composite index, including immediate technical success after surgery and no displacement of the aorta and branch stent grafts in CTA 12 months after surgery, and no type I and type III endoleaks, the branch stent was unobstructed, and no second surgical intervention occurred during the follow-up period.	12 months after operation
Secondary	All-cause mortality, aortic dissection-related mortality, serious adverse events, device-related adverse events, incidence of left upper limb ischemia.	All-cause mortality 30 days, 6 months, and 12 months after operation.; Mortality related to aortic dissection 30 days, 6 months, and 12 months after operation.; Incidence of serious adverse events 30 days, 6 months, and 12 months after operation.; The incidence of device-related adverse events 30 days, 6 months, and 12 months after operation.; Incidence of left upper limb ischemia 30 days, 6 months, and 12 months after operation.	30 days, 6 months, and 12 months after operation
Secondary	The incidence of type I or type III endoleaks	Record the endoleaks shown in the postoperative DSA or CTA images. Intraoperative endoleaks and adjuvant treatment are not recorded. Endoleaks that occurred after the completion of the operation and those that were not treated in the same subject at different follow-up stages were counted once.	during operation, 30 days after operation, 6 months, 12 months
Secondary	Incidence of displacement of aorta and branch stent graft	Observe and record CTA at 6 months and 12 months after operation to check the stent displacement, the main stent and branch stents are recorded and evaluated. Displacement was defined as the displacement of the node aorta and branch stent grafts by more than 10 mm compared to the 30th day after surgery.	6 months and 12 months after surgery
Secondary	Postoperative branch vessel patency rate	Observe and record CTA on the 30th day, 6 months, and 12 months after operation to evaluate the revascularization of branch vessels, whether there is occlusion, stenosis or thrombosis in the stent. Postoperative branch vessel stenosis =50% is considered unobstructed.	30 days, 6 months, 12 months after surgery
Secondary	Success rate of remodeling of aortic dissection	Compare the results of CTA before operation and on the 30th day, 6th month and 12th month after operation, the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the aortic dissection vascular stent to determine whether the blood vessel is successfully remodeled.	30 days, 6 months, 12 months after surgery
Secondary	Incidence of conversion to thoracotomy or secondary interventional surgery due to aortic dissection	To evaluate whether the subject was converted to thoracotomy or secondary interventional surgery due to aortic dissection.	immediately after the surgery, 30 days after operation, 6 months, 12 months, 2~5 years