Guo's Subclavian Artery Reconstruction: The Prospective,... | NCT04765605

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WeFlow-Tbranch Stent Graft System	Experimental	Participants will be treated with WeFlow-Tbranch Stent Graft System	Device: WeFlow-Tbranch Stent Graft System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
All-cause mortality, aortic dissection-related mortality, serious adverse events, device-related adverse events, incidence of left upper limb ischemia.	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Facility	Status	City	State	ZIP	Country	Contacts
Chinese PLA General Hospital		Beijing			China
Fuwai Hospital, Chinese Academy of Medical Sciences