Aortic Arch AneurysmTRACENCT07067840
Triple Branched Stent Graft System for Aortic Arch Lesions
A study testing Treated with the triple branched stent graft system in people with Aortic Arch Aneurysm and Aortic Arch Pseudoaneurysm, run by Changhai Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm, Aortic Arch Ulcer
- What is being tested?
- Treated with the triple branched stent graft system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Song, Dr. contact
China1 site, 1 recruiting
- Recruiting
Shanghai Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, 200433
Qingsheng Lu, Doctor, +8613917292504, luqs@newvascular.cn
Qingsheng Lu, Doctor
About this study
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.
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?
Read more
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.
- Being tested
- Treated with the triple branched stent graft system
- Keywords
- triple branched stent graft, aortic arch, aortic ulcer, aortic aneurysm
- Medical subject headings
- Aneurysm, Aortic Arch, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treated with the triple branched stent graft systemDevice
Participants treated with the triple branched stent graft system
| Study group | Role | What they receive |
|---|---|---|
| Treated with the triple branched stent graft system | Experimental | Participant group that treated with the triple branched stent graft system Receives: Device: Treated with the triple branched stent graft system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days postoperatively
Secondary outcomes (11)
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.
Measured: 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%.
Measured: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
All-cause Mortality Rate
The rate of death from any cause postoperatively.
Measured: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Aortic Lesion-related Mortality Rate
The rate of death related to aortic lesions.
Measured: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Paraplegia Incidence Rate
Assessed using the spinal ischemia grading system, with the grade recorded.
Measured: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Stroke Incidence Rate
Assessed using the Modified Rankin Scale (MRS), with the grade recorded.
Measured: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Secondary Intervention Incidence Rate
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.
Measured: 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
The incidence of stent fracture, twist, or collapse detected by imaging postoperatively.
Measured: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Stent Migration Incidence Rate
The incidence of stent migration ≥10mm.
Measured: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Endoleak Incidence Rate
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.
Measured: 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
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.
Measured: pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start3 Nov 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Arch AneurysmStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongnan Hospital, The University of Hong Kong-Shenzhen Hospital, West China Hospital, Meizhou People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Third Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of University of South China, First Affiliated Hospital of Chongqing Medical University, Guangyuan Central Hospital, Jining First People's Hospital, The First People's Hospital of Yunnan, Dalian Municipal Central Hospital, Tianjin Chest Hospital, Xiangya Hospital of Central South University, The Affiliated Hospital Of Southwest Medical University, Kunming Yan'an Hospital
- Responsible party
- Principal investigator, Qingsheng Lu, Changhai Hospital
- Investigators
- Qingsheng Lu, Dr., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067840
- Sponsor's protocol ID
- TRACE-1
- Acronym
- TRACE
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07067840
- Acronym / sponsor ID
- TRACE / TRACE-1
- Keywords
- triple branched stent graft, aortic arch, aortic ulcer, aortic aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Zhongnan Hospital, The University of Hong Kong-Shenzhen Hospital, West China Hospital, Meizhou People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Third Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of University of South China, First Affiliated Hospital of Chongqing Medical University, Guangyuan Central Hospital, Jining First People's Hospital, The First People's Hospital of Yunnan, Dalian Municipal Central Hospital, Tianjin Chest Hospital, Xiangya Hospital of Central South University, The Affiliated Hospital Of Southwest Medical University, Kunming Yan'an Hospital
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with the triple branched stent graft system | Experimental | Device: Treated with the triple branched stent graft systemParticipant group that treated with the triple branched stent graft system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
Key exclusion criteria (19 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treated with the triple branched stent graft systemParticipants treated with the triple branched stent graft system | Device | Treated with the triple branched stent graft system |
Primary outcome
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.
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Song, Dr. contact
Qingsheng Lu, Dr. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treated with the triple branched stent graft system in people with Aortic Arch Aneurysm and Aortic Arch Pseudoaneurysm, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingsheng Lu, Dr. (+8613917292504, luqs@newvascular.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month Treatment Success Rate (time frame: 12 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.