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| ID | Type | Description | Link |
|---|---|---|---|
| 2023ZD0504300 | Other Grant/Funding Number | Noncommunicable Chronic Disease-National Science and Technology Major Project |
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This is a prospective, multicenter, non-inferior, parallel-controlled observational study. This study aims to compare clinical outcomes of endovascular treatment for acute high-risk type B aortic dissection in the acute phase versus the subacute phase. No interventions will be imposed on the patients' standard treatment. Patients with acute high-risk type B aortic dissection will be grouped based on the actual timing of their treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with acute high-risk type B aortic dissection | Acute (2-14 days) high-risk type B aortic dissection (defined by one or more of the following: aortic maximum diameter >40 mm, primary tear on the lesser curvature, false lumen diameter >22 mm, entry tear >10 mm, aortic diameter growth >5 mm during hospitalization, imaging evidence of visceral malperfusion, haemorrhagic pleural effusion, need for readmission, or recurrent chest pain). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute Phase | Procedure | Patients with acute high-risk type B aortic dissection received endovascular treatment in acute phase (2-14days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day all-cause mortality rate | paraplegia, stroke, new entry tear, renal/liver dysfunction, type I/II/R endoleak | 30 days following the operation |
| 30-day complication rate | access site complications | 30 days following the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | rupture, stent-induced new entry, ischemia (renal/limb/intestinal/spinal), endoleak, dissection aneurysm, stroke, venous thrombosis, all-cause death. | 12 months following the operation |
| aortic remodeling |
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Inclusion Criteria:
Exclusion Criteria:
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Acute (2-14 days) high-risk type B aortic dissection (defined by one or more of the following: aortic maximum diameter >40 mm, primary tear on the lesser curvature, false lumen diameter >22 mm, entry tear >10 mm, aortic diameter growth >5 mm during hospitalization, imaging evidence of visceral malperfusion, haemorrhagic pleural effusion, need for readmission, or recurrent chest pain).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Shanghai | 200032 | China |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Subacute Phase | Procedure | Patients with acute high-risk type B aortic dissection received endovascular treatment in subacute phase (≥14days) |
|
aortic diameter growth > 5 mm in 12 months; dissection aneurysm
| 12 months following the operation |
| 5-year all-cause mortality rate | long-term outcome | 5 years following the operation |
| 5-year complication rate | long-term outcome | 5 years following the operation |
| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |