Aortic arch single-branch covered stent graft for treating aortic dissection

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

This trial tests a single-branch covered stent graft in adults with Stanford Type B aortic dissection who need revascularization of the left subclavian artery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Changsha)
• Trial ID: NCT06915545 on ClinicalTrials.gov

What this trial studies

The trial implants an aortic arch single-branch covered stent graft to treat dissections that involve the aortic arch while preserving flow to the left subclavian artery. Eligible patients are adults 18–80 years with Stanford Type B aortic dissection who meet specific anatomical measurements for landing zones and vascular access. The protocol requires strict adherence to procedural and follow-up schedules to collect safety and efficacy data. Outcomes will focus on device performance, complications, and patency of the left subclavian artery over specified follow-up visits.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–80 with Stanford Type B aortic dissection requiring left subclavian revascularization who meet the specified aortic and branch artery size and length criteria and have suitable arterial access.

Not a fit: Patients who previously had endovascular repair involving the region, those with incompatible anatomy (landing zones or vessel diameters outside the listed ranges), or those with Type A dissection or outside the age range are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could offer a less invasive way to repair the aortic arch while maintaining blood flow to the left arm and reducing the need for open surgery.

How similar studies have performed: Branched endografts and thoracic endovascular aortic repair (TEVAR) approaches have shown promising results in other reports, but single-branch arch devices are a more recent development with limited large-scale data.

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.

Where this trial is running

Changsha

• Second Xiangya Hospital of Central South University — Changsha, China (Recruiting)

Study contacts

• Principal investigator: chang shu, Professor — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: chang shu, Professor

Conditions Aortic Dissection