Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
NCT Number: NCT06520774
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Arch Aneurysm|Penetrating Aortic Ulcer
Interventions: DEVICE: Concave Supra-arch Branched Stent-Graft System
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Collaborators: Second Xiangya Hospital of Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 103
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2031-10-30

Summary:
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

Primary Outcome Measures: Incidence 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., within 30 days post-surgery
Secondary Outcome Measures: Immediate technical success rate, Immediate technical success refers to the successful navigation of the delivery system to the predetermined location, the successful deployment of the system, the safe withdrawal of the delivery system from the body, and the successful reconstruction of the branch arteries., Immediate intraoperative|Incidence rate of aneurysmal enlargement at 6 and 12 months postoperatively, aneurysmal enlargement defined as a maximum aortic diameter increase of \> 5 mm, 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., 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., 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%, 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, 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., 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., 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, liver failure, intestinal necrosis, kidney failure, stroke (excluding TIA), permanent paraplegia, myocardial infarction, or respiratory failure., 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., 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., 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., 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., 6 months, 12 months, and 2-5 years postoperatively