Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease

Phase 4

• Conditions: Coronary Artery Disease; Aortic Atherosclerotic Disease
• Interventions: Procedure: One-stop strategy group

• Registration Number: NCT03563768
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-10
• Study First Submitted QC: 2018-06-10
• Last Update Submitted: 2018-06-10
• Study First Posted: 2018-06-20
• Last Update Posted: 2018-06-20
• Study Start: 2018-06-30
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One-stop strategy group	One-stop strategy group	Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)

Primary Outcome Measures

Name	Time	Method
Perioperative major bleeding (BARC≥3 grade)	12 months

Secondary Outcome Measures

Name	Time	Method
Difference of incidence of bleeding events (BARC 2 grade) between two groups	12 months
Difference of incidence of all-cause death between two groups	12 months
Difference of incidence of myocardial infarction between two groups	12 months
Difference of operative success rate between two groups	12 months
Difference of incidence of Stent thrombosis between two groups	12 months
Composite of average in-patient time and average cost during hospitalization	12 months
Difference of incidence of rupture of aorta between two groups	12 months
Difference of incidence of pseudoaneurysm between two groups	12 months

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences, Fuwai Hospital; 🇨🇳 Beijing, Beijing, China