Study on the Aortic Arch Single Branch Stent Graft System

Study on the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Dissection
• Intervention / Treatment: Device: Aortic Arch Single Branch Covered Stent System

Detailed Description

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
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: chang shu, Professor; Phone Number: 13607444222; Email: changshu01@yahoo.com

Study Locations

• China
  • Changsha, China
    • Recruiting
    • Second Xiangya Hospital of Central South University
    • Contact: Chang Shu, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 80 years, gender unrestricted.
• Patients are diagnosed with Stanford Type B aortic dissection and need revascularization of the left subclavian artery.

• Anatomical criteria:

  • The diameter range of the proximal aortic landing zone is 20-42 mm.
  • The length of the proximal aortic landing zone (the distance from the posterior edge of the left common carotid artery orifice to the first intimal tear) is ≥15 mm.
  • The distance between the left common carotid artery and the left subclavian artery is ≥5 mm.
  • The length of the left subclavian artery landing zone is ≥25 mm, and the diameter range of the landing zone is 5-15 mm.
  • Suitable access to the femoral artery, iliac artery, and upper limb artery.
• Patients understand the purpose of the study, volunteer to participate, and are willing to complete follow - up visits as required by the protocol.

Exclusion Criteria:

• Previously undergone endovascular interventional treatment involving the aortic arch, or having a history of aortic surgical repair surgery, which affects the implantation and evaluation of the single branched covered stent system of the aortic arch.
• Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area pose challenges. Such conditions may easily prevent covered stents from adhering to the vessel wall or affect stent patency.
• Infectious aortic diseases, giant cell arteritis, Marfan syndrome (or other hereditary connective tissue diseases).
• Patients with systemic or local infections that may increase the risk of infection of the endovascular graft.
• Patients who have received abdominal aortic surgical or endovascular interventional surgery within the past 3 months.
• Patients who have had a stroke attack (excluding transient ischemic attack, TIA) or myocardial infarction within the past 3 months.
• Patients known to be allergic to contrast agents, stent materials, and delivery device materials (referring to nitinol, Dacron, PTFE, nylon polymer materials).
• Patients known to have contraindications to anticoagulant and antiplatelet drugs.
• Patients intolerant to general anesthesia.
• Patients with severe abnormalities in liver, kidney, and cardiac function before the operation [Subjects with a serum creatinine level exceeding 150 μmol/L; Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 5 times the upper limit of the normal value; Subjects with serum total bilirubin (STB) exceeding 2 times the upper limit of the normal value; Subjects with a left ventricular ejection fraction lower than 50% as indicated by echocardiography.].
• Patients whose expected lifespan is shorter than 1 year.
• Female patients who are planning to conceive, are currently pregnant, or are breastfeeding.
• Patients whom, in the researcher's judgment, are not appropriate candidates for endovascular treatment.
• Patients who have been involved in other clinical studies and have not withdrawn from or exited the respective study groups within the three months preceding the screening period of this present study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aortic Arch Single Branch Covered Stent System; Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch	Device: Aortic Arch Single Branch Covered Stent System; to Evaluate the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence 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.	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.	intraoperative and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality Refers to deaths from any cause that occur within the follow-up time points.	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.	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.	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.	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.	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.	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 .	6 and 12 months postoperatively
The patency rate of the branch vessel	Branch vessel patency is defined as stenosis of ≤50%	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.	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.	Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Principal Investigator: chang shu, Professor, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: P158CT(CN)-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No