Aortic Atherosclerotic Disease, Coronary Artery Disease
Conditions
Keywords
coronary artery disease, aortic atherosclerotic disease, one-stop, endovascular aortic repair, percutaneous coronary intervention
Brief summary
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
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.
Interventions
PROCEDUREOne-stop strategy group
Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative major bleeding (BARC≥3 grade) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 Stent thrombosis between two groups | 12 months |
| Difference of operative success rate between two groups | 12 months |
| Difference of incidence of all-cause death between two groups | 12 months |
| Composite of average in-patient time and average cost during hospitalization | 12 months |
| Difference of incidence of pseudoaneurysm between two groups | 12 months |
Countries
China
Contacts
Primary ContactMin Yang, MD
Backup ContactKuo Zhang, MD, PhD
Outcome results
None listed