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

Hangzhou Endonom Medtech

Status

Active, not recruiting

Conditions

Type B Aortic Dissection

Treatments

Device: WeFlow-Tbranch Stent Graft System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04765605

WeFlow001

Details and patient eligibility

About

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 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.

Enrollment

120 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.