The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
135
to Evaluate the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
Second Xiangya Hospital of Central South University
Changsha, China
RECRUITINGIncidence rate for freedom from major adverse events (MAE) within 30 days postoperatively
Major adverse events refer to the occurrences of all-cause death, myocardial infarction, renal failure, liver failure, respiratory failure, paraplegia, ischemic stroke, intestinal necrosis. Among them, renal failure means that it leads to persistent dialysis, kidney transplantation, or other fatal outcomes. Respiratory failure means that it leads to a significantly prolonged intubation time, tracheotomy, deterioration of lung function, or other fatal outcomes. Intestinal necrosis refers to intestinal ischemia that requires intestinal resection or leads to other fatal outcomes.
Time frame: pre-discharge up to 14 days and 30 days post-surgery
Procedural success rate of aortic dissection treatment 12 months postoperatively
The composite endpoints include immediate technical success post-procedure and, at the 12-month CTA reexamination, the absence of displacement of the main aortic and branch stents, no type I or III endoleaks, patency of the branch stents, and no secondary surgical interventions during follow-up.
Time frame: intraoperative and 12 months postoperatively
All-cause mortality
All-cause mortality Refers to deaths from any cause that occur within the follow-up time points.
Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Mortality rate related to aortic dissection
Mortality rate related to aortic dissection refers to the death caused by the rupture of aortic dissection or the endovascular treatment of aortic dissection.
Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Incidence rate of severe adverse events
Serious adverse events refer to those occurring during the process of a clinical trial that lead to death or a serious deterioration of the health condition. This includes fatal diseases or injuries, permanent defects in body structures or body functions, the need for hospitalization or an extended hospital stay, and the requirement for medical or surgical interventions to prevent permanent defects in body structures or body functions.
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Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Incidence rate of Device-related adverse events
Adverse events refer to adverse medical events that occur during the process of a clinical trial, regardless of whether they are related to the medical device used in the trial. However, normal postoperative stress responses should be distinguished, such as fever, discomfort in the chest and back, etc. If, upon the judgment of the researcher, it is determined to be a normal postoperative stress response, there is no need to record it as an adverse event of the medical device. Adverse events related to the medical device refer to situations that are determined by the researcher to be definitely related, possibly related, or undeterminable in relation to the medical device used in the trial.
Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
The incidence rate of left upper limb ischemia
Left upper limb ischemia may present with weakness, coldness, pain, and numbness in the left upper limb. The ulnar artery, radial artery, and brachial artery may show weakened or absent pulsation.
Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively
Incidence rate of Type I/III endoleak
A Type I endoleak occurs when there is a gap between the graft and the vessel wall at the "seal zones." This gap allows blood to flow alongside the graft into the aneurysm sac, creating pressure within the sac and increasing the risk of rupture. Type I endoleaks often occur when the aneurysm's anatomy is unsuitable for endovascular aneurysm repair (EVAR) or due to inappropriate device selection. However, vessel dilation over time can also cause this type of endoleak. Immediate attention is typically required because of the high risk of sac enlargement and rupture.
Time frame: Intraoperative, pre-discharge（up to 14 days）, within 30 days and 6 and 12 months postoperatively
Incidence rate of stent graft migration
Migration is defined as the single branched covered stent system of the aortic arch having a displacement of more than 10 mm compared with its position before discharge .
Time frame: 6 and 12 months postoperatively
The patency rate of the branch vessel
Branch vessel patency is defined as stenosis of ≤50%
Time frame: Pre-discharge up to 14 days, 6 and 12 months postoperatively
The success rate of vascular remodeling for aortic dissection
Evaluate the expansion of the true lumen and the thrombosis of the false lumen at the sites covered by the vascular stents for aortic dissection, so as to determine whether the vascular remodeling is successful.
Time frame: within 30 days and 6 and 12 months postoperatively
The incidence rate of conversion to thoracotomy or secondary interventional surgery due to aortic dissection
Evaluate whether the subjects have been converted to thoracotomy or secondary interventional surgery due to aortic dissection.
Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively