Clinical trial NCT04765605: Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)
Official title: Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type B Aortic Dissection
Keywords: Type B Aortic Dissection
proximal left subclavian artery
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of no major adverse events within 30 days after surgery.
timeFrame: 30 days after operation
measure: Treatment success rate of aortic dissection 12 months after operation
timeFrame: 12 months after operation
Secondary outcomes:
measure: All-cause mortality, aortic dissection-related mortality, serious adverse events, device-related adverse events, incidence of left upper limb ischemia.
timeFrame: 30 days, 6 months, and 12 months after operation
measure: The incidence of type I or type III endoleaks
timeFrame: during operation, 30 days after operation, 6 months, 12 months
measure: Incidence of displacement of aorta and branch stent graft
timeFrame: 6 months and 12 months after surgery
measure: Postoperative branch vessel patency rate
timeFrame: 30 days, 6 months, 12 months after surgery
measure: Success rate of remodeling of aortic dissection
timeFrame: 30 days, 6 months, 12 months after surgery
measure: Incidence of conversion to thoracotomy or secondary interventional surgery due to aortic dissection
timeFrame: immediately after the surgery, 30 days after operation, 6 months, 12 months, 2~5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Foshan
country: China
facility: Foshan First People's Hospital
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
city: Luzhou
country: China
facility: Affiliated Hospital of Southwest Medical University
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
city: Nanjing
country: China
facility: Nanjing Gulou Hospital
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Jiaotong University Affiliated Ninth People's Hospital
city: Shanghai
country: China
facility: The Second Affiliated Hospital of Naval Medical University
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Shijia Zhuang
country: China
facility: The First Hospital of Hebei Medical University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
city: Tianjin
country: China
facility: Tianjin Chest Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Xian
country: China
facility: The First Affiliated Hospital of PLA Air Force Military Medical University
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Chinese PLA General Hospital
name: Wei Guo, Professor
role: PRINCIPAL_INVESTIGATOR
References: