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

Overview

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.

Full Title of Study: “Guo’s Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 25, 2022

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: WeFlow-Tbranch Stent Graft System
    • Participants will be treated with WeFlow-Tbranch Stent Graft System

Clinical Trial Outcome Measures

Primary Measures

  • Rate of no major adverse events within 30 days after surgery.
    • Time Frame: 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
    • Time Frame: 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.

Secondary Measures

  • All-cause mortality, aortic dissection-related mortality, serious adverse events, device-related adverse events, incidence of left upper limb ischemia.
    • Time Frame: 30 days, 6 months, and 12 months after operation
    • 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.
  • The incidence of type I or type III endoleaks
    • Time Frame: during operation, 30 days after operation, 6 months, 12 months
    • 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.
  • Incidence of displacement of aorta and branch stent graft
    • Time Frame: 6 months and 12 months after surgery
    • 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.
  • Postoperative branch vessel patency rate
    • Time Frame: 30 days, 6 months, 12 months after surgery
    • 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.
  • Success rate of remodeling of aortic dissection
    • Time Frame: 30 days, 6 months, 12 months after surgery
    • 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.
  • Incidence of conversion to thoracotomy or secondary interventional surgery due to aortic dissection
    • Time Frame: immediately after the surgery, 30 days after operation, 6 months, 12 months, 2~5 years
    • To evaluate whether the subject was converted to thoracotomy or secondary interventional surgery due to aortic dissection.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hangzhou Endonom Medtech Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wei Guo, Professor, Principal Investigator, Chinese PLA General Hospital
  • Overall Contact(s)
    • Wei Guo, 13910758706, Pla301dml@vip.sina.com

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