Triple Branched Stent Graft System for Aortic Arch Lesions

NCT07067840 | Not Yet Recruiting

• 1 other identifier: TRACE-1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Arch Aneurysm; Aortic Arch Pseudoaneurysm; Aortic Arch Ulcer

Keywords

triple branched stent graft; aortic arch; aortic ulcer; aortic aneurysm

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 days postoperatively

Secondary Outcomes (11)

• Immediate Technical Success Rate

  Immediately after the surgery

• Branch Stent Patency Rate

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

• All-cause Mortality Rate

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

• Aortic Lesion-related Mortality Rate

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

• Paraplegia Incidence Rate

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

Study Arms (1)

Treated with the triple branched stent graft system

EXPERIMENTAL

Participant group that treated with the triple branched stent graft system

Device: Treated with the triple branched stent graft system

Interventions

Treated with the triple branched stent graft system DEVICE

Participants treated with the triple branched stent graft system

Treated with the triple branched stent graft system

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Aneurysm, Aortic Arch; Aortic Aneurysm

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Qingsheng Lu, Dr.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingsheng Lu, Dr.

CONTACT

+8613917292504; luqs@newvascular.cn

Chao Song, Dr.

CONTACT

songc@newvascular.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)