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The study is designed to evaluate the safety and effectiveness of the "one-stop" endovascular intervention strategy for patients with concomitant coronary artery disease and aortic atherosclerotic disease. It is a registration study, which will consecutively enroll at least 50 patients with at least 30 subjects receiving one-stop strategy.
It is a registration study, at least 50 patients will be consecutively enrolled and then be allocated into one-stop strategy group or staging strategy group with at least 30 subjects receiving one-stop strategy. In one stop strategy group, percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR). In staging strategy group, PCI will be performed several days after EVAR. The safety and effectiveness will be assessed between the two groups untill 1 year after the operation. The economic index will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One stop strategy group | Experimental | Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR) |
|
| Staging strategy group | No Intervention | PCI will be performed several days after EVAR |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One stop strategy group | Procedure | Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Events | The incidence of a composite endpoint of all-cause mortality, myocardial infarction, rupture of aorta, hematoma, bleeding events (BARC≥2 grade), pseudoaneurysm, stent thrombosis | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Operative success rate | 12 months | |
| Average in-patient time | 12 months | |
| Average cost during hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Yang, MD | Contact | +861088396173 | 13810727489@163.com | |
| Kuo Zhang, MD | Contact | +8618813019602 | kzhang23@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi-Da Tang, MD, PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | Beijing | Beijing Municipality | 100037 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |