Clinical Trial: BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease: Pilot Study

Brief Summary: The purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold) implantation with optimal medical therapy can improve the outcome of patients with variant angina and moderate coronary artery disease.

Detailed Summary:
Sponsor: Seung-Jung Park

Current Primary Outcome: Composite of all cause death, myocardial infarction, and angina-related hospitalization [ Time Frame: 2year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Variant angina [ Time Frame: 2year ]
    by Ergonovine test
  • All cause death [ Time Frame: 2year ]
  • Cardiac death [ Time Frame: 2year ]
  • Repeat revascularization [ Time Frame: 2year ]
  • Scaffold thrombosis [ Time Frame: 2year ]
  • Myocardial infarction [ Time Frame: 2year ]
  • Stroke [ Time Frame: 2year ]
  • Angina-related hospitalization [ Time Frame: 2year ]
  • Composite event of death or myocardial infarction [ Time Frame: 2year ]
  • Composite event of cardiac death or myocardial infarction [ Time Frame: 2year ]


Original Secondary Outcome:

  • Variant angina [ Time Frame: 2year ]
    by Ergonovine test
  • All cause death [ Time Frame: 2year ]
  • Cardiac death [ Time Frame: 2year ]
  • cardiac arrest [ Time Frame: 2year ]
  • Myocardial infarction [ Time Frame: 2year ]
  • Angina-related hospitalization [ Time Frame: 2year ]
  • Composite event of death or myocardial infarction [ Time Frame: 2year ]
  • Composite event of cardiac death or myocardial infarction [ Time Frame: 2year ]


Information By: Asan Medical Center

Dates:
Date Received: October 12, 2016
Date Started: February 10, 2017
Date Completion: December 31, 2019
Last Updated: January 18, 2017
Last Verified: January 2017