Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch ā¦ (NCT04765605) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)
China120 participantsStarted 2020-12-25
Plain-language 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.
Who can participate
Age range18 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Patients aged 18 to 80 years old, no gender limitation;
ā. 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;
ā. Diagnosed as Stanford type B aortic dissection and needed reconstruction of the left subclavian artery;
ā. The diameter of the proximal anchoring area (the aorta at the posterior edge of the left common carotid artery) range: 18ļ½42mm;
ā. The length of the proximal anchoring area (the distance from the rear edge of the left common carotid artery opening to the first breach) ā„15mm;
ā. The distance between the left common carotid artery and the left subclavian artery ā„5mm;
ā. The distance between the left vertebral artery and the opening of the left subclavian artery is ā„15mm, the diameter of the starting part of the left subclavian artery is 6ļ½20mm
ā. With proper femoral artery, iliac artery, and brachial artery access, endovascular treatment of the aorta can be performed.
Exclusion criteria
ā. Pregnant, breastfeeding or cannot contraception during the trial period;
ā. Participated in clinical trials of other drugs or devices during the same period;
ā
What they're measuring
1
Rate of no major adverse events within 30 days after surgery.
Timeframe: 30 days after operation
2
Treatment success rate of aortic dissection 12 months after operation
. 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;
ā. Allergic to contrast agents, anesthetics, patches, and delivery materials;
ā. Cannot tolerate anesthesia;
ā. Severe liver, kidney, lung, and heart function abnormalities before surgery \[Serum creatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination\];
ā. True/false thoracic aortic aneurysm
ā. History of myocardial infarction, TIA or cerebral infarction within the past 3 months;