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This is a prospective, multicenter, randomized controlled clinical study. A total of 198 eligible subjects will be enrolled and randomly assigned in a 1:1 ratio to either the Study Group or the Control Group. Subjects in the Study Group will receive surgical treatment using the study device (Type A Dissection Total Endovascular Reconstruction System) in addition to standard medical therapy following the Total Arch Replacement with Frozen Elephant Trunk. Subjects in the Control Group will continue standard medical therapy without surgical treatment using the study device following Total Arch Replacement with Frozen Elephant Trunk. Clinical follow-ups will be conducted at 30 days (±7 days), 6 months (±30 days), and 12 months (±30 days) post-enrollment to evaluate the effectiveness and safety of the study device.
After all subjects complete the 12-month (±30 days) follow-up, a statistical analysis will be performed and the results will be submitted for the study device registration application. Long-term follow-up will continue for 2-5 years post-enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Active Comparator | Standard medical therapy (e.g., blood pressure and heart rate control) plus endovascular repair with Study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection. |
|
| Control Group | Active Comparator | Standard medical therapy (e.g., blood pressure and heart rate control) without endovascular repair with Study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical treatment | Device | Endovascular repair with study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in False Lumen Volume of the Distal Aortic Dissection at 12 months | Defined as the difference in the false lumen volume of the distal aortic dissection (distal to the frozen elephant trunk stent, including thrombosis portions) at baseline and 12 months (±30 days) post-enrollment among subjects in the Study group and Control group, respectively | 12 months (±30 days) post-enrollment |
| The incidence of major adverse events (MAEs) within 30 days | The percentage of subjects in the study or control group who experience any MAEs within 30 days (±7 days) after enrollment, relative to the total number of subjects in each group. | 30 days (±7 days) after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Success Rate (%) (Immediate post-procedure) (Study Group only) | The percentage of subjects in the study group who achieved procedure success immediately after procedure out of the total number of subjects in the study group. Procedure success is defined as successful delivery and positioning of the system, accurate deployment of the stent, successful retrieval of the delivery system, no conversion to open surgical thoracotomy during the procedure, subject survival at the end of the procedure, and no Type I or III endoleak on angiography in the covered stent-graft segment. |
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Inclusion Criteria:
Age ≥18 years, male or female.
Within 90 days of onset of Stanford Type A Aortic Dissection and 30 days post Total Arch Replacement with Frozen Elephant Trunk treatment (assessed via CTA at 30±7 days post open surgery):
Voluntarily participate in this study and provide signed informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Hu | Contact | +86 18682560211 | jiahu@wchscu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
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| Standard of Care (Investigator Choice) | Drug | Standard medical therapy (e.g., blood pressure and heart rate control) |
|
| Immediately post procedure |
| Treatment Success Rate (%) (12 months) (Study Group only) | The percentage of subjects in the study group who achieved treatment success at 12 months (±30 days) after enrollment out of the total number of subjects in the study group. | 12 months (±30 days) after enrollment |
| Change in True Lumen Volume of the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years) | The difference in the volume change of the true lumen of distal aortic dissection (distal to the frozen elephant trunk stent, thoracic and abdominal segments) at baseline, 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) post-enrollment among subjects in the Study group and Control group, respectively. | 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment. |
| Change in False Lumen Volume of the Distal Aortic Dissection (at 30 days, 6 months, 2-5 years) | The difference of change in the false lumen volume of distal aortic dissection (distal to the frozen elephant trunk stent, thoracic and abdominal segments, including thrombosis portions) at baseline, 30 days (±7 days), 6 months (±30 days), and 2-5 years (±30 days) post-enrollment among subjects in the Study group and Control group, respectively. | 30 days (±7 days), 6 months (±30 days), and 2-5 years (±30 days) after enrollment |
| Change in Maximum Diameter of the Distal Aorta (True + False Lumen) (at 30 days, 6, 12 months, 2-5 years) | The difference in the maximum diameter change of the entire distal aorta (true lumen + false lumen, distal to the frozen elephant trunk stent, thoracic and abdominal segments) at baseline, 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) ost-enrollment among subjects in the Study group and Control group, respectively. | 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment |
| Thrombosis Status of the False Lumen in the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years) | The qualitative and/or quantitative assessment of thrombosis status in the false lumen of distal aortic dissection (aortic segment from the distal end of the frozen elephant trunk stent to the superior edge of the celiac trunk origin) for subjects in the study or control group at 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) post-enrollment, based on CTA imaging and aortic reconstruction models. | 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment |
| Rate of Secondary Intervention Related to the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years) | The percentage of subjects in the study or control group who meet the indications for secondary intervention related to distal aortic dissection within 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) post-enrollment, relative to the total number of subjects in each group. | 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment. |
| Survival Rate (6, 12 months, 2-5 years) | The percentage of subjects in the study or control group with no all-cause death or aortic-related death at 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment, relative to the total number of subjects in each group. | 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment |
| Incidence of MAE (6, 12 months, 2-5 years) | MAEs include any of the following aortic-related events: death, stroke, myocardial infarction, paraplegia/spinal cord ischemia, intestinal ischemia/necrosis requiring intervention, new-onset renal failure requiring replacement therapy, or respiratory failure requiring prolonged mechanical ventilation or reintubation. | 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment |
| Incidence of Paraplegia/Spinal Cord Ischemia (at 30 days, 6, 12 months, 2-5 years) | The percentage of subjects in the study or control group who develop paraplegia or spinal cord ischemia within 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment, relative to the total number of subjects in each group. | 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment. |
| Incidence of Acute Kidney Injury (at 30 days, 6, 12 months, 2-5 years) | The percentage of subjects in the study or control group who develop acute kidney injury within 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment, relative to the total number of subjects in each group. | 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment. |
| Incidence of Stroke (at 30 days, 6, 12 months, 2-5 years) | The percentage of subjects in the study or control group who experienced a stroke within 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment, relative to the total number of subjects in each group. | 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment |
| Incidence of Stent Migration (at 30 days, 6, 12 months) (Study Group only) | The percentage of subjects in the study group with stent displacement within 30 days (±7 days), 6 months (±30 days), and 12 months (±30 days) after enrollment, relative to the total number of subjects in each group. | 30 days (±7 days), 6 months (±30 days), and 12 months (±30 days) after enrollment. |
| Incidence of AE/SAEs | AE refers to any unfavorable medical event occurring during a clinical trial, whether or not related to the study device. | Through study completion, an average of 5 year |
| Incidence of Device Deficiencies (Study Group only) | A device deficiency refers to any unreasonable risk that may endanger human health and safety during normal use of the medical device in a clinical trial, such as label errors, quality issues, malfunctions, etc. | Through study completion, an average of 5 year |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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