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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Aortic Atherosclerotic Disease
• Intervention / Treatment: Procedure: One-stop strategy group

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Chinese Academy of Medical Sciences, Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One-stop strategy group; Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)	Procedure: One-stop strategy group; Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)
No Intervention: Staging strategy group; PCI will be performed several days after EVAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Perioperative major bleeding (BARC≥3 grade)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference of operative success rate 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 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 pseudoaneurysm 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

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 10, 2018
• First Submitted That Met QC Criteria: June 10, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 10, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; coronary artery disease; endovascular aortic repair; aortic atherosclerotic disease; one-stop
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2018-2-4032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No