Clinical Trial: Drug-eluting Stents vs. Drug-coated Balloon for Preventing Recurrent In-stent Restenosis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Treatment of Drug-Eluting Stent REstenosis Using Drug-Eluting STents vs. Drug-COated Balloon for Preventing REcurrent In-Stent Restenosis

Brief Summary: The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of drug eluting stent restenosis.

Detailed Summary:
Sponsor: Seung-Jung Park

Current Primary Outcome: Late luminal loss [ Time Frame: 9months ]

Late luminal loss at 9 months angiographic follow-up.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Death [ Time Frame: 1 year ]
  • Myocardial infarction [ Time Frame: 1 year ]
  • Target lesion revascularization [ Time Frame: 1 year ]
  • Target vessel revascularization [ Time Frame: 1 year ]
  • Stent thrombosis [ Time Frame: 1 year ]
  • In-segment or in-stent restenosis at 9 month angiographic follow-up [ Time Frame: 1 year ]
  • Procedural success [ Time Frame: 3day ]

    defined as achievement of a final diameter stenosis of <30% by QCA(Quantitative Coronary Angiography) using any percutaneous method, without the occurrence of death, Q wave Myocardial Infarction, or repeat revascularization of the target lesion during the hospital stay.

    participants will be followed for the duration of hospital stay, an expected average of 3days.



Original Secondary Outcome: clinical follow up [ Time Frame: 1 year ]

  • Death
  • Myocardial infarction
  • Target lesion revascularization
  • Target vessel revascularization
  • Stent thrombosis
  • In-segment or in-stent restenosis at 9 month angiographic follow-up
  • Procedural success defined as achievement of a final diameter stenosis of <30% by QCA(Quantitative Coronary Angiography) using any percutaneous method, without the occurrence of death, Q wave Myocardial Infarction, or repeat revascularization of the target lesion during the hospital stay.
  • IVUS(Intravascular ultrasound), OCT(Optical coherence tomography), and VH(Virtual Histology) analysis


Information By: Asan Medical Center

Dates:
Date Received: October 17, 2013
Date Started: April 18, 2013
Date Completion:
Last Updated: February 23, 2017
Last Verified: February 2017