Aortic Atherosclerotic Disease, Coronary Artery Disease
Conditions
Keywords
coronary artery disease, aortic atherosclerotic disease, one-stop, percutaneous coronary intervention, endovascular aortic repair
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.
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
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Events | 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
| Measure | Time frame |
|---|---|
| Operative success rate | 12 months |
| Average in-patient time | 12 months |
| Average cost during hospitalization | 12 months |
Countries
China
Contacts
Primary ContactMin Yang, MD
Backup ContactKuo Zhang, MD
Outcome results
None listed