Clinical trial NCT03563768: Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease
Official title: Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Aortic Atherosclerotic Disease
Keywords: coronary artery disease
aortic atherosclerotic disease
one-stop
endovascular aortic repair
percutaneous coronary intervention
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perioperative major bleeding (BARC≥3 grade)
timeFrame: 12 months
Secondary outcomes:
measure: Difference of operative success rate between two groups
timeFrame: 12 months
measure: Difference of incidence of all-cause death between two groups
timeFrame: 12 months
measure: Difference of incidence of myocardial infarction between two groups
timeFrame: 12 months
measure: Difference of incidence of rupture of aorta between two groups
timeFrame: 12 months
measure: Difference of incidence of bleeding events (BARC 2 grade) between two groups
timeFrame: 12 months
measure: Difference of incidence of pseudoaneurysm between two groups
timeFrame: 12 months
measure: Difference of incidence of Stent thrombosis between two groups
timeFrame: 12 months
measure: Composite of average in-patient time and average cost during hospitalization
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences, Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Yi-Da Tang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: