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| Name | Class |
|---|---|
| Zhongnan Hospital | OTHER |
| The University of Hong Kong-Shenzhen Hospital | OTHER |
| West China Hospital | OTHER |
| Meizhou People's Hospital |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated with the triple branched stent graft system | Experimental | Participant group that treated with the triple branched stent graft system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treated with the triple branched stent graft system | Device | Participants treated with the triple branched stent graft system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the surgery |
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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:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingsheng Lu, Dr. | Contact | +8613917292504 | luqs@newvascular.cn | |
| Chao Song, Dr. | Contact | songc@newvascular.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qingsheng Lu, Dr. | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changhai Hospital, Naval Medical University | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D000094626 | Aneurysm, Aortic Arch |
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| The Third Affiliated Hospital of Wenzhou Medical University | OTHER |
| The First Affiliated Hospital of University of South China | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Guangyuan Central Hospital | UNKNOWN |
| Jining First People's Hospital | OTHER |
| The First People's Hospital of Yunnan | OTHER |
| Dalian Municipal Central Hospital | OTHER |
| Tianjin Chest Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| The Affiliated Hospital Of Southwest Medical University | OTHER |
| Kunming Yan'an Hospital | UNKNOWN |
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| 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%. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively |
| D001018 |
| Aortic Diseases |