Triple Branched Stent Graft System for Aortic Arch Lesions

Official title

Safety and Efficacy of the Triple Branched Covered Stent Graft System for the Treatment of Aortic Arch Lesions: a Prospective, Multicenter, Single-Arm Trial.

Overview

The goal of this clinical trial is to evaluate the safety and efficacy of the Triple Branched Covered Stent Graft System in treating aortic arch lesions. The main questions it aims to answer are: * Does the Triple Branched Covered Stent Graft System achieve a 12-month treatment success rate that meets or exceeds the predefined target value? * What is the 30-day major adverse event (MAE) rate following the use of the Triple Branched Covered Stent Graft System? Researchers will use a single-arm study design with predefined target values for the primary endpoints to assess the performance of the stent system. Participants will: * Undergo a comprehensive screening process to determine eligibility based on specific inclusion and exclusion criteria. * Receive the Triple Branched Covered Stent Graft System implantation as part of the treatment for their aortic arch lesions. * Attend follow-up visits at specified intervals (e.g., pre-discharge, 30 days post-surgery, 6 months, 12 months, and annually up to 5 years) for evaluations including imaging studies (CTA) and clinical assessments. * Report any adverse events or changes in their health status during the follow-up period.

Interventions

• Device Treated with the triple branched stent graft system
  Participants treated with the triple branched stent graft system

Primary outcome measures

• 12-month Treatment Success Rate [Time frame: 12 months postoperatively]
• 30-day Major Adverse Event Rate [Time frame: 30 days postoperatively]

Secondary outcome measures (11)

• Immediate Technical Success Rate [Time frame: Immediately after the surgery]
• Branch Stent Patency Rate [Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively]
• All-cause Mortality Rate [Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively]
• Aortic Lesion-related Mortality Rate [Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively]
• Paraplegia Incidence Rate [Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively]
• Stroke Incidence Rate [Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively]
• Secondary Intervention Incidence Rate [Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively]
• Stent Fracture/Twist/Collapse Incidence Rate [Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively]
• Stent Migration Incidence Rate [Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively]
• Endoleak Incidence Rate [Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively]
• Maximum Diameter and Diameter Change of Aortic Lesion [Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively]

Eligibility criteria

• Inclusion Criteria：

• Patients aged 18-80 years.
• Diagnosed with aortic arch lesions that require treatment, including true aortic arch aneurysms, false aortic arch aneurysms, and aortic arch ulcers.
• The investigator determines that the subject is suitable for endovascular therapy.
• The subject understands the purpose of the trial, voluntarily agrees to participate, and is willing to undergo follow-up.
• Anatomical conditions:

• Ascending aorta length ≥50 mm.
• Ascending aorta diameter ≥26 mm and ≤46 mm.
• Proximal landing zone length ≥20 mm.
• Brachiocephalic artery diameter ≤19 mm and ≥9 mm, with a length ≥20 mm.
• Left common carotid artery and left subclavian artery diameter ≤13 mm and ≥5 mm, with a left common carotid artery length ≥20 mm, and the distance from the left vertebral artery opening to the left subclavian artery opening on the aorta ≥20 mm.
• The investigator assesses the subject as a high-risk patient for open surgery or with significant contraindications to open surgery.
• Exclusion Criteria

• Pregnant or breastfeeding women.
• Patients diagnosed with connective tissue diseases related to the aorta (e.g., Marfan syndrome).
• Infectious aortic diseases or Takayasu arteritis.
• Patients who have undergone endovascular treatment of the ascending aorta or aortic arch.
• Patients with a known allergy to nickel-titanium alloy, contrast agents, or other relevant materials.
• Severe renal failure (creatinine levels more than twice the upper limit of normal; dialysis patients are excluded).
• Hematological abnormalities:

• Leukopenia (WBC < 3×10⁹/L).
• Anemia (Hb < 70 g/L).
• Coagulation disorders: thrombocytopenia (PLT count < 50×10⁹/L).
• Heart transplant recipients.
• History of myocardial infarction or stroke within the past 3 months.
• Heart function class IV (NYHA classification).
• Active infections, such as bacteremia or sepsis.
• Patients with an expected survival of less than 12 months.
• Patients with aortic valve replacement with a mechanical valve that would interfere with the safe introduction of the trial device.
• Subjects participating in other drug or medical device clinical trials and have not yet completed the primary endpoints of those trials.
• Poor compliance, with an expectation of inability to attend follow-up visits.
• Other conditions deemed by the investigator as unsuitable for endovascular therapy, such as severe vascular stenosis, calcification, tortuosity, thrombosis, or inability to cooperate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Changhai Hospital, Naval Medical University — Shanghai

Identifiers

NCT: NCT07067840 · TRACE-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗