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

NCT04765605 | Active Not Recruiting

• 1 other identifier: WeFlow001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 29

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.

Conditions

Type B Aortic Dissection

Keywords

Type B Aortic Dissection; proximal left subclavian artery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• All-cause mortality, aortic dissection-related mortality, serious adverse events, device-related adverse events, incidence of left upper limb ischemia.

  30 days, 6 months, and 12 months after operation

• The incidence of type I or type III endoleaks

  during operation, 30 days after operation, 6 months, 12 months

• Incidence of displacement of aorta and branch stent graft

  6 months and 12 months after surgery

• Postoperative branch vessel patency rate

  30 days, 6 months, 12 months after surgery

• Success rate of remodeling of aortic dissection

  30 days, 6 months, 12 months after surgery

Study Arms (1)

WeFlow-Tbranch Stent Graft System

EXPERIMENTAL

Participants will be treated with WeFlow-Tbranch Stent Graft System

Device: WeFlow-Tbranch Stent Graft System

Interventions

WeFlow-Tbranch Stent Graft System DEVICE

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

WeFlow-Tbranch Stent Graft System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 80 years old, no gender limitation;
• 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;
• Diagnosed as Stanford type B aortic dissection and needed reconstruction of the left subclavian artery;
• The diameter of the proximal anchoring area (the aorta at the posterior edge of the left common carotid artery) range: 18～42mm;
• 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;
• The distance between the left common carotid artery and the left subclavian artery ≥5mm;
• 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
• With proper femoral artery, iliac artery, and brachial artery access, endovascular treatment of the aorta can be performed.

You may not qualify if:

• Pregnant, breastfeeding or cannot contraception during the trial period;
• Participated in clinical trials of other drugs or devices during the same period;
• 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;
• Allergic to contrast agents, anesthetics, patches, and delivery materials;
• Cannot tolerate anesthesia;
• Severe liver, kidney, lung, and heart function abnormalities before surgery \[Serum creatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination\];
• True/false thoracic aortic aneurysm
• History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
• Contraindications to antiplatelet drugs and anticoagulants
• Life expectancy is less than 12 months (such as advanced malignant tumors)
• Acute systemic infection
• Severe stenosis or calcification in the anchoring area at the proximal end of the stent, easily lead to the stent graft difficult adherent
• Investigator judged that not suitable for interventional treatment.

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Study Sites (29)

Chinese PLA General Hospital

Beijing, China

Location

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Xiangya Hospital of Central South University

Changsha, China

Location

West China Hospital of Sichuan University

Chengdu, China

Location

Foshan First People's Hospital

Foshan, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Anhui Provincial Hospital

Hefei, China

Location

Shandong Provincial Hospital

Jinan, China

Location

The First People's Hospital of Yunnan Province

Kunming, China

Location

Affiliated Hospital of Southwest Medical University

Luzhou, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location

Jiangsu Provincial People's Hospital

Nanjing, China

Location

Nanjing Gulou Hospital

Nanjing, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Shanghai Jiaotong University Affiliated Ninth People's Hospital

Shanghai, China

Location

The Second Affiliated Hospital of Naval Medical University

Shanghai, China

Location

Zhongshan Hospital, Fudan University

Shanghai, China

Location

The First Hospital of Hebei Medical University

Shijia Zhuang, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

Shanxi Bethune Hospital

Taiyuan, China

Location

Tianjin Chest Hospital

Tianjin, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

The First Affiliated Hospital of PLA Air Force Military Medical University

Xi'an, China

Location

Yantai Yuhuangding Hospital

Yantai, China

Location

First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Study Officials

• Wei Guo, Professor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 21, 2021
• Study Start: December 25, 2020
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: April 30, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (29)