Evaluation of the Strategy of One-stop Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Strategy of One-stop Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease

Conditions
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Coronary Artery Disease, Aortic Atherosclerotic Disease

Intervention / Treatment
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* Procedure: One-stop strategy group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 18 years to 75years, male or female; Aortic atherosclerotic disease with indication of EVAR; Coronary heart disease with indication of PCI; Provided informed consent. Exclusion Criteria: Acute aortic dissection Acute coronary syndrome Dysfunction of coagulation system Patients with gastrointestinal hemorrhage Known allergy to contrasts or antiplatelet drugs Renal dysfunction (GFR≤60ml/min) Patient with multi-branch coronary preferred CABG

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-stop strategy group<br>Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR) | Procedure: One-stop strategy group<br>* Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)<br>|
| No Intervention: Staging strategy group<br>PCI will be performed several days after EVAR | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative major bleeding (BARC≥3 grade) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, aortic atherosclerotic disease, one-stop, endovascular aortic repair, percutaneous coronary intervention