Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Rate of no major adverse events within 30 days after surgery. — 30 days after operation
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. - Treatment success rate of aortic dissection 12 months after operation — 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.
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Xi'an | China | |
| Yantai Yuhuangding Hospital | Yantai | China | |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
More Hangzhou Endonom Medtech Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04765605 on ClinicalTrials.gov ↗ ← All trials in China