Triple Branched Stent Graft System for Aortic Arch Lesions

N/ANot Yet RecruitingNCT07067840

Changhai Hospital96 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Arch Aneurysm Aortic Arch Pseudoaneurysm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

* Inclusion Criteria： 1. Patients aged 18-80 years. 2. Diagnosed with aortic arch lesions that require treatment, including true aortic arch aneurysms, false aortic arch aneurysms, and aortic arch ulcers. 3. The investigator determines that the subject is suitable for endovascular therapy. 4. The subject understands the purpose of the trial, voluntarily agrees to participate, and is willing to undergo follow-up. 5. 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. 6. The investigator assesses the subject as a high-risk patient for open surgery or with significant contraindications to open surgery. * Exclusion Criteria 1. Pregnant or breastfeeding women. 2. Patients diagnosed with connective tissue diseases related to the aorta (e.g., Marfan syndrome). 3. Infectious aortic diseases or Takayasu arteritis. 4. Patients who have undergone endovascular treatment of the ascending aorta or aortic arch. 5. Patients with a known allergy to nickel-titanium alloy, contrast agents, or other relevant materials. 6. Severe renal failure (creatinine levels more than twice the upper limit of normal; dialysis patients are excluded). 7. Hematological abnormalities: * Leukopenia (WBC \< 3×10⁹/L). * Anemia (Hb \< 70 g/L). * Coagulation disorders: thrombocytopenia (PLT count \< 50×10⁹/L). 8. Heart transplant recipients. 9. History of myocardial infarction or stroke within the past 3 months. 10. Heart function class IV (NYHA classification). 11. Active infections, such as bacteremia or sepsis. 12. Patients with an expected survival of less than 12 months. 13. Patients with aortic valve replacement with a mechanical valve that would interfere with the safe introduction of the trial device. 14. Subjects participating in other drug or medical device clinical trials and have not yet completed the primary endpoints of those trials. 15. Poor compliance, with an expectation of inability to attend follow-up visits. 16. Other conditions deemed by the investigator as unsuitable for endovascular therapy, such as severe vascular stenosis, calcification, tortuosity, thrombosis, or inability to cooperate.

Outcomes

Primary Outcomes

12-month Treatment Success Rate

Definition: Treatment success at 12 months is defined as immediate technical success, with no device/aneurysm-related death or unplanned secondary intervention postoperatively, and no increase in the diameter of the treated aorta segment (aneurysm or ulcer lesion diameter increased by ≥5mm) due to type I/III endoleak on CTA imaging follow-up at 12 months.

Time frame: 12 months postoperatively

30-day Major Adverse Event Rate

Any of the following events occurring within 30 days: 1.All-cause death: Any death from any cause within 30 days. 2.Disabling stroke: Defined as a Modified Rankin Scale (MRS) score ≥2 due to neurological deficits, with an increase of at least one grade from baseline. 3.Persistent paraplegia: Defined as a spinal ischemia grade ≥3 according to the spinal ischemia grading system. 4.Renal failure: New-onset persistent renal failure with a creatinine increase of more than 50% above preoperative levels, requiring dialysis. 5.Myocardial infarction: Clinically diagnosed as a new acute myocardial infarction, or requiring Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG). 6.Respiratory failure: Intubation for more than 1 week during hospitalization.

Time frame: 30 days postoperatively

Secondary Outcomes

Immediate Technical Success Rate

The main and branch stents are successfully delivered to the predetermined position, accurately positioned and successfully deployed, the main and branch delivery systems are safely removed from the body, there is no branch stent stenosis or occlusion, and no device/aneurysm-related death or unplanned additional surgery.

Time frame: Immediately after the surgery

Branch Stent Patency Rate

Based on imaging follow-up using Digital Subtraction Angiography (DSA) or Computed Tomographic Angiography (CTA), the degree of stenosis in the branches of the brachiocephalic artery, left common carotid artery, and left subclavian artery is ≤50%.