Study on the Aortic Arch Single Branch Stent Graft System

Launched by LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with a specific type of aortic dissection, which is a serious condition affecting the aorta, the large artery that carries blood from the heart. The study will assess the safety and effectiveness of a device called the Aortic Arch Single Branch Stent Graft System, designed to help improve blood flow in patients who need treatment for the left subclavian artery, a branch of the aorta. This trial is not yet recruiting participants, but when it does, it will include people aged 18 to 80 who have been diagnosed with Stanford Type B aortic dissection and meet certain medical criteria.

To be eligible for the trial, participants must have specific measurements in the aorta and access points for the procedure. They should also understand the study’s purpose and agree to follow-up visits. However, some people may not be eligible, such as those who have had previous surgeries on the aorta, severe health issues, or certain medical conditions. If you’re considering participating in this trial, you can expect to work closely with medical professionals and will be monitored throughout the process to ensure your safety.

Gender

ALL

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.