The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
The physician must strictly adhere to the clinical study protocol and shall not deviate from or substantially alter it. However, in cases of emergency where there is an immediate risk to the subjects that must be eliminated immediately, a report may be submitted in written form afterward. During the study, any amendments to the clinical study protocol, informed consent documents, requests for deviation, and the resumption of a suspended clinical study must receive written approval from the Ethics Committee.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
103
To evaluate the efficacy and safety of Concave Supra-arch Branched Stent-Graft System for endovascular treatment of Aortic Arch Diseases
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGIncidence of composite endpoints
Composite endpoints refer to the occurrence of any of the following within 30 days post-surgery: all-cause mortality, disabling stroke, or permanent paraplegia.
Time frame: within 30 days post-surgery
The clinical treatment success rate within 12 months
The 12-month clinical treatment success rate is a composite endpoint that includes immediate technical success after surgery and the absence of the following conditions at 12 months postoperatively: death, displacement of the aortic or branch covered stents on CTA follow-up, Type I or III endoleak, branch stent occlusion, and the need for secondary surgical intervention during the follow-up period.
Time frame: pre-discharge (up to 14 days) and 12 months postoperatively
Immediate technical success rate
Immediate technical success refers to the successful delivery of the delivery system to the predetermined position, successful deployment of the system, safe removal of the delivery system from the body, and absence of type I and III endoleaks that require intervention on angiography at the end of the procedure, with all branch stents being patent.
Time frame: Immediate intraoperative
Incidence of increase in the maximum diameter of the aneurysm/depth of ulceration by more than 5 mm at 6 months and 12 months postoperatively.
Increase in the maximum diameter of the aneurysm/depth of ulceration\> 5 mm
Time frame: 6 and 12 months postoperatively
Incidence rate of Type I/III endoleak at Intraoperative, pre-discharge, 6 and 12 months postoperatively
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. A Type III endoleak results from a defect or misalignment between the components of the endograft. Similar to a Type I endoleak, a Type III endoleak causes systemic pressure within the aneurysm sac, increasing the risk of rupture. Consequently, Type III endoleaks also necessitate urgent attention. The definition of "pre-discharge" is either the discharge date or the 14th postoperative day, whichever occurs first.
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Second Xiangya Hospital of Central South University
Changsha, China
RECRUITINGWest China Hospital, Sichuan University
Chengdu, China
RECRUITINGThe First Affiliated Hospital of Fujian Medical University
Fuzhou, China
RECRUITINGUnion Hospital Affiliated to Fujian Medical University
Fuzhou, China
RECRUITINGThe First Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, China
RECRUITINGThe First Affiliated Hospital of Kunming Medical University
Kunming, China
RECRUITINGThe First People's Hospital of Yunnan Province
Kunming, China
RECRUITINGYunnan Fuwai Cardiovascular Disease Hospital
Kunming, China
RECRUITINGJiangsu Provincial People's Hospital
Nanjing, China
RECRUITING...and 7 more locations
Time frame: Intraoperative, pre-discharge（up to 14 days）, 6 and 12 months postoperatively
Incidence rate of stent graft migration at 6 and 12 months postoperatively
Migration is defined according to reporting standards as a stent graft shift of more than 10 mm relative to a primary anatomic landmark, or any displacement that results in symptoms or necessitates therapy. A standardized measurement protocol was employed in accordance with the reporting guidelines.
Time frame: 6 and 12 months postoperatively
The patency rate of the branch vessel at 6 and 12 months postoperatively
Branch vessel patency is defined as stenosis of ≤50%
Time frame: 6 and 12 months postoperatively
Incidence rate of secondary surgical interventions related to the aortic arch and its branch arteries before discharge , at the 6 months and 12 months , and at 2-5 years postoperatively
Incidence of secondary surgical interventions related to the aortic arch and its branch arteries
Time frame: before discharge （up to 14 days）, at the 6 months and 12 months , and at 2-5 years postoperative
Incidence rate of aneurysm rupture at Intraoperative, pre-discharge, 6 and 12 months, 2-5 years postoperatively
An aneurysm is an abnormal bulge or ballooning in the wall of a blood vessel. If an aneurysm ruptures, it causes internal bleeding, which can often be fatal.
Time frame: Intraoperative, pre-discharge (up to 14 days）, 6 and 12 months 2-5 years postoperatively
Incidence rate of delivery system-related complications during perioperative period (from surgery to 30 days after surgery)
The incidence rate of related complications during the perioperative period (from surgery to 30 days post-surgery) includes intraoperative conversion surgeries due to delivery devices, as well as bleeding, hematoma, and pseudoaneurysm occurring along the delivery access route.
Time frame: perioperative period (from surgery to 30 days after surgery)
Incidence rate of MAE at Intraoperative, pre-discharge and within 30 days postoperatively
A Major Adverse Event (MAE) is defined as any occurrence of all-cause mortality, intestinal necrosis, kidney failure, stroke (excluding TIA), permanent paraplegia, myocardial infarction, or respiratory failure.
Time frame: Intraoperative, pre-discharge（up to 14 days） and within 30 days postoperatively
All-cause mortality at 6 months, 12 months, and 2-5 years postoperatively
All-cause mortality refers to the rate of death from any cause within a specific population over a defined period of time.
Time frame: 6 months, 12 months, and 2-5 years postoperatively
Aortic-related mortality at 6 months, 12 months, and 2-5 years postoperatively
Aortic-related mortality refers to the proportion of deaths attributed to aortic conditions within a specific population over a defined period of time.
Time frame: 6 months, 12 months, and 2-5 years postoperatively
Incidence rate of severe adverse events at 6 months, 12 months, and 2-5 years postoperatively
A serious adverse event (SAE) in a clinical trial refers to any incident that results in death or a significant deterioration in health. This includes life-threatening illnesses or injuries, permanent impairment of a body structure or function, hospitalization or extended hospital stay, and medical or surgical interventions necessary to prevent permanent damage to physical structure or function. Additionally, SAEs encompass events causing fetal distress, fetal death, or congenital anomalies or defects.
Time frame: 6 months, 12 months, and 2-5 years postoperatively
Incidence rate of Device-related adverse events at 6 months, 12 months, and 2-5 years postoperatively
Medical device adverse events are unexpected incidents that occur during or after the use of a medical device by a patient. The World Health Organization (WHO) defines an adverse event as "a problem that can or does result in permanent impairment, injury, or death to the patient or the user." This definition implies two key requirements for determining a medical device adverse event. First, the event must be related to the usage of the medical device. Second, it must be assessed whether the use of the medical device could cause direct harm or potential harm.
Time frame: 6 months, 12 months, and 2-5 years postoperatively