Study on the Aortic Arch Single Branch Stent Graft System

NCT ID: NCT06915545

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2031-06-30

Brief Summary

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

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

Conditions

Aortic Dissection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Aortic Arch Single Branch Covered Stent System

Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

Group Type: EXPERIMENTAL

Aortic Arch Single Branch Covered Stent System

Intervention Type: DEVICE

to Evaluate the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lifetech Scientific (Shenzhen) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

chang shu, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Second Xiangya Hospital of Central South University

Changsha, , China

Site Status: RECRUITING

Countries

China

Central Contacts

chang shu, Professor

Role: CONTACT

changshu01@yahoo.com

13607444222

Facility Contacts

chang shu, Professor

Role: primary

Other Identifiers

P158CT(CN)-01

Identifier Type: -

Identifier Source: org_study_id