Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a prospective, randomized, controlled, exploratory trail to evaluate the strategy of "one-stop" endovascular treatment for concomitant coronary artery disease and aortic atherosclerotic disease.
60 patients will be allocated randomly in a 1:1 ratio into one-stop strategy group or staging strategy group. In one-stop strategy group, percutaneous coronary intervention (PCI) will be performed on the same operating room 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 two groups 1 year after the operation. The economic index will be evaluated as well as.
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|
| Perioperative major bleeding (BARC≥3 grade) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of operative success rate between two groups | 12 months | |
| Difference of incidence of all-cause death between two groups | 12 months | |
| Difference of incidence of myocardial infarction between two groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Yang, MD | Contact | 00861088396173 | 13810727489@163.com | |
| Kuo Zhang, MD, PhD | Contact | 008618813019602 | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| Difference of incidence of rupture of aorta between two groups | 12 months |
| Difference of incidence of bleeding events (BARC 2 grade) between two groups | 12 months |
| Difference of incidence of pseudoaneurysm between two groups | 12 months |
| Difference of incidence of Stent thrombosis between two groups | 12 months |
| Composite of average in-patient time and average cost during hospitalization | 12 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided