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NCT Number: NCT07067840

Triple Branched Stent Graft System for Aortic Arch Lesions

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.

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Key information

Conditions

Aortic Arch Aneurysm Aneurysm Aneurysm, Aortic Arch Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Arch Pseudoaneurysm Aortic Arch Ulcer Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

Location contact

Qingsheng Lu, Doctor

CONTACT

[email protected]

+8613917292504

Qingsheng Lu, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Treated with the triple branched stent graft system

Device

Participants treated with the triple branched stent graft system

Primary outcomes

  1. 12-month Treatment Success Rate

    Time frame: 12 months postoperatively

    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.

  2. 30-day Major Adverse Event Rate

    Time frame: 30 days postoperatively

    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.

Secondary outcomes

  1. Immediate Technical Success Rate

    Time frame: Immediately after the surgery

    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.

  2. 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

    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%.

  3. 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

    The rate of death from any cause postoperatively.

  4. 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

    The rate of death related to aortic lesions.

  5. Paraplegia Incidence Rate

    Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively

    Assessed using the spinal ischemia grading system, with the grade recorded.

  6. Stroke Incidence Rate

    Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively

    Assessed using the Modified Rankin Scale (MRS), with the grade recorded.

  7. 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

    Includes open or endovascular surgery caused by type I/III endoleak, aortic growth (caused by type I/III endoleak), aortic rupture, branch stenosis or occlusion, stent migration, or new-onset dissection at the proximal or distal end, excluding planned expected surgery.

  8. 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

    The incidence of stent fracture, twist, or collapse detected by imaging postoperatively.

  9. 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

    The incidence of stent migration ≥10mm.

  10. Endoleak Incidence Rate

    Time frame: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively

    Based on imaging results from DSA or CTA, the incidence of endoleak postoperatively. Endoleak is classified as follows: Type I refers to blood reflux at the proximal and distal ends of the stent; Type II refers to retrograde blood flow from the aortic branch vessels; Type III refers to blood reflux at the site of stent membrane rupture or stent connection; Type IV refers to leakage of the covered stent membrane.

  11. 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

    The maximum diameter of the aortic lesion segment is recorded preoperatively and during postoperative follow-up, measured perpendicular to the centerline. The proportions of maximum diameter reduction ≥5mm, maximum diameter increase ≥5mm, and maximum diameter change less than 5mm are calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Song, Dr.

CONTACT

[email protected]

Qingsheng Lu, Dr.

CONTACT

[email protected]

+8613917292504

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Dalian Municipal Central Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Chongqing Medical University
  • Guangyuan Central Hospital
  • Jining First People's Hospital
  • Kunming Yan'an Hospital
  • Meizhou People's Hospital
  • The Affiliated Hospital Of Southwest Medical University
  • The First Affiliated Hospital of University of South China
  • The First People's Hospital of Yunnan
  • The Third Affiliated Hospital of Wenzhou Medical University
  • The University of Hong Kong-Shenzhen Hospital
  • Tianjin Chest Hospital
  • West China Hospital
  • Xiangya Hospital of Central South University
  • Zhongnan Hospital

Registry information

Official study 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.

Acronym: TRACE

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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