This study is a single-arm, open-label, multi-center clinical trial evaluating the safety and efficacy of endovascular treatment for retrograde dissection involving the ascending aorta that is not suitable for open surgery. The aim is to assess the short-term (30 days) and medium- to long-term (6 months and 12 months) safety and efficacy of endovascular treatment in patients with retrograde dissection involving the ascending aorta who are not suitable for open surgery. The study plans to include patients with dissection confirmed by imaging, with the tear located in the aortic arch or descending aorta and extending retrogradely to the ascending aorta, and the most distal segment of the dissection is at least 2 cm away from the coronary artery ostia. These patients have been evaluated by cardiac surgery and found to be unsuitable for open surgery, with significant risks or risks outweighing benefits associated with open surgery. This is a single-arm, open-label, multi-center study, and no blinding or randomization will be used, nor will stratification factors be set. After successful screening, the subjects will undergo endovascular treatment for aortic dissection (stent implantation) during the operation. The subjects will be followed up for one year after the operation, and the safety and efficacy of endovascular treatment for retrograde dissection involving the ascending aorta will be evaluated based on the subjects' survival status, the occurrence of surgery and disease-related complications, and the recovery of the disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
149
Endovascular treatment of aortic dissection (stent implantation)
Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe death events and major adverse cardiovascular and cerebrovascular events (MACCE) caused by any reason within 30 days after endovascular treatment, as well as their incidence rates
Time frame: 30 days
The incidence rate of surgery-related complications
Time frame: 12 months
Success rate of one-year stent implantation technique
Time frame: 12 months
The all-cause mortality rates for 6 months and 12 months
Time frame: 12 months
The incidence rates of major adverse cardiovascular and cerebrovascular events within 6 months and 12 months
Time frame: 12 months
The rates of re-intervention for aortic dissection within 6 months and 12 months
Time frame: 12 months
The incidence rates of complications related to aortic dissection for 6 months and 12 months
Time frame: 12 months
Aortic imaging remodeling assessment: Changes in the true lumen diameters of the ascending aorta, aortic arch, and descending aorta at 6 months and 12 months after surgery, and the proportion of false lumen reduction or complete thrombosis
Time frame: 12 months
Quality of life assessment: The SF-36 scale was used to evaluate the patients' quality of life scores before the surgery, 6 months after the surgery, and 12 months after the surgery.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.