A prospective, single-center, first in man study to evaluate the safety and efficacy of Endopatch System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the Chronic Stanford B type aortic dissection proximal tear.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
The patch system for aortic dissection tear is composed of a dissection tear patch system and an adjustable bend conveyor. The patch system is composed of a patch and a conveying steel cable. The patch is pre-installed on the conveying steel cable.
Chinese PLA General Hospital
Beijing, China
RECRUITINGNo 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.
Time frame: 30 days after operation
The success rate of entry tears closure 6 months after operation.
The success rate of intimal tears closure at 6 months is a composite index, including immediate technical success after the operation and no leakage of the intimal tears sealed by the DSA 6 months after the operation, no displacement of the patch, and no second occurrence during the follow-up period.
Time frame: 6 months after operation
All-cause mortality, aortic dissection-related mortality, serious adverse events, and device-related adverse events.
1. All-cause mortality 30 days, 6 months, and 12 months after operation; 2. Mortality related to aortic dissection 30 days, 6 months, and 12 months after operation; 3. Incidence of serious adverse events 30 days, 6 months, and 12 months after operation; 4. Incidence of device-related adverse events 30 days, 6 months, and 12 months after operation.
Time frame: 30 days, 6 months, and 12 months after operation
False lumen thrombosis of the descending thoracic aorta 1 month, 6 months, 12 months after operation
False lumen thrombosis of the descending thoracic aorta 1 month, 6 months, 12 months after operation.
Time frame: 1 month, 6 months, 12 months after operation
Change of false lumen diameter in descending thoracic aorta 1 month, 6 months, 12 months after operation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change of false lumen diameter in descending thoracic aorta 1 month, 6 months, 12 months after operation.
Time frame: 1 month, 6 months, 12 months after operation