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Active, not recruiting Not applicable

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

NCT04765605 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2020-12-25
Last updated
2024-04-30

Condition(s) studied

Type B Aortic Dissection

Investigational drug(s) / intervention(s)

WeFlow-Tbranch Stent Graft System

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 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)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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