Status:
ACTIVE_NOT_RECRUITING
Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)
Lead Sponsor:
Hangzhou Endonom Medtech Co., Ltd.
Conditions:
Type B Aortic Dissection
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 (...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04765605
Start Date
December 25 2020
End Date
December 25 2026
Last Update
April 30 2024
Active Locations (29)
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1
Chinese PLA General Hospital
Beijing, China
2
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
3
Xiangya Hospital of Central South University
Changsha, China
4
West China Hospital of Sichuan University
Chengdu, China