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This study is a single-arm, open-label, multi-center clinical trial evaluating the safety and efficacy of endovascular treatment for retrograde dissection involving the ascending aorta that is not suitable for open surgery. The aim is to assess the short-term (30 days) and medium- to long-term (6 months and 12 months) safety and efficacy of endovascular treatment in patients with retrograde dissection involving the ascending aorta who are not suitable for open surgery. The study plans to include patients with dissection confirmed by imaging, with the tear located in the aortic arch or descending aorta and extending retrogradely to the ascending aorta, and the most distal segment of the dissection is at least 2 cm away from the coronary artery ostia. These patients have been evaluated by cardiac surgery and found to be unsuitable for open surgery, with significant risks or risks outweighing benefits associated with open surgery. This is a single-arm, open-label, multi-center study, and no blinding or randomization will be used, nor will stratification factors be set. After successful screening, the subjects will undergo endovascular treatment for aortic dissection (stent implantation) during the operation. The subjects will be followed up for one year after the operation, and the safety and efficacy of endovascular treatment for retrograde dissection involving the ascending aorta will be evaluated based on the subjects' survival status, the occurrence of surgery and disease-related complications, and the recovery of the disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular treatment of aortic dissection (stent implantation) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment of aortic dissection (stent implantation) | Device | Endovascular treatment of aortic dissection (stent implantation) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The death events and major adverse cardiovascular and cerebrovascular events (MACCE) caused by any reason within 30 days after endovascular treatment, as well as their incidence rates | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence rate of surgery-related complications | 12 months | |
| Success rate of one-year stent implantation technique | 12 months | |
| The all-cause mortality rates for 6 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junyi Yan, M.D. | Contact | +8613480161737 | yanjy0117@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital | Recruiting | Shanghai | Shanghai Municipality | 201801 | China |
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| ID | Term |
|---|---|
| D000094630 | Dissection, Ascending Aorta |
| ID | Term |
|---|---|
| D000094629 | Dissection, Thoracic Aorta |
| D000784 | Aortic Dissection |
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
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| 12 months |
| The incidence rates of major adverse cardiovascular and cerebrovascular events within 6 months and 12 months | 12 months |
| The rates of re-intervention for aortic dissection within 6 months and 12 months | 12 months |
| The incidence rates of complications related to aortic dissection for 6 months and 12 months | 12 months |
| Aortic imaging remodeling assessment: Changes in the true lumen diameters of the ascending aorta, aortic arch, and descending aorta at 6 months and 12 months after surgery, and the proportion of false lumen reduction or complete thrombosis | 12 months |
| Quality of life assessment: The SF-36 scale was used to evaluate the patients' quality of life scores before the surgery, 6 months after the surgery, and 12 months after the surgery. | 12 months |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |