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Study on the Aortic Arch Single Branch Stent Graft System | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT06915545•Lifetech Scientific (Shenzhen) Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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 \[Subjects with a serum creatinine level exceeding 150 μmol/L; Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 5 times the upper limit of the normal value; Subjects with serum total bilirubin (STB) exceeding 2 times the upper limit of the normal value; Subjects with a left ventricular ejection fraction lower than 50% as indicated by echocardiography.\].
+4 more criteria

Locations (1)

Second Xiangya Hospital of Central South University

Changsha, China

Key Dates

Start Date

April 30, 2025

Primary Completion Date

April 30, 2027

Completion Date

June 30, 2031

Last Updated

June 11, 2025

Enrollment

135

ESTIMATED participants

Conditions

Aortic Dissection

Interventions

Aortic Arch Single Branch Covered Stent System

DEVICE

Contacts

chang shu, Professor

CONTACT

13607444222 changshu01@yahoo.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study on the Aortic Arch Single Branch Stent Graft System

Inclusion Criteria

Exclusion Criteria

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