Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Treatment-Emergent Adverse Events
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Yi-Da Tang
Clinical professor
Chinese Academy of Medical Sciences, Fuwai Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Treatment-Emergent Adverse Events
Time Frame: 12 months
The incidence of a composite endpoint of all-cause mortality, myocardial infarction, rupture of aorta, hematoma, bleeding events (BARC≥2 grade), pseudoaneurysm, stent thrombosis
Secondary Outcomes
- Average cost during hospitalization(12 months)
- Operative success rate(12 months)
- Average in-patient time(12 months)