A prospective, single-center, first in man study to evaluate the safety and efficacy of WeFlow-EndoSeal Aorta Vascular Plug System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the dissecting aneurysm of descending thoracic aorta after aortic dissection repair.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The Aorta Vascular Plug System for false lumen is composed of a vascular plug system and an adjustable bend conveyor. The plug system is composed of a patch and a conveying steel cable. The plug is pre-installed on the conveying steel cable.
Chinese PLA Gencral Hosptial
Beijing, Beijing Municipality, China
RECRUITINGThe People's Hospital of Gaozhou
Gaozhou, Guangdong, China
RECRUITINGZhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGNo major adverse events within 30 days after operation.
Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory 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.
Time frame: 30 days after operation
All-cause mortality
All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes.
Time frame: 30 days, 6 months, and 12 months after operation
Aortic dissection-related mortality,
Refers to mortality caused by a ruptured aortic dissection or endovascular interventional treatment.
Time frame: 30 days, 6 months, and 12 months after operation
Serious adverse events.
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Time frame: 30 days, 6 months, and 12 months after operation
False lumen thrombosis of the descending thoracic aorta
False lumen thrombosis of the descending thoracic aorta (no thrombosis, partial thrombosis, complete thrombosis) observed by postoperative CTA review.
Time frame: 1 month, 6 months, and 12 months after operation
Aortic dissection progression under control
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Aortic dissection progression under control is defined as maximum increase in the diameter of false lumen diameter in descending thoracic aorta was ≤ 5 mm when compared with preoperative aortic dissection as of postoperative CTA review.
Time frame: 1 month, 6 months, and 12 months after operation