Evaluation of One-stop Strategy of EVAR and PCI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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 the indication of EVAR; Coronary heart disease with the 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: 75 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: Non-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 |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative success rate |  | 12 months | 
| Average in-patient time |  | 12 months | 
| 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, percutaneous coronary intervention, endovascular aortic repair