Clinical Trial: Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective, Multi-center, Randomized, Controlled Clinical Trial, Assessing the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of RESTORE Paclitaxel eluting balloon in the treatment of Chinese patients with coronary heart disease and small vessel lesions in comparison with RESOLUTE Zotarolimus eluting stent.

Detailed Summary:
Sponsor: ZhuHai Cardionovum Medical Device Co., Ltd.

Current Primary Outcome: In-segment diameter stenosis(%). [ Time Frame: 9 months after the operation. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The success rate of intervention treatment (%),including device success, lesion success and clinical success. [ Time Frame: 1-2 days. ]
  • In-device diameter stenosis (%) of the target lesion. [ Time Frame: 9 months after the operation. ]
  • cardiac death. [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  • myocardial infarction related to the target vessel. [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  • target lesion revascularization driven by ischemia. [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  • all-cause death [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  • myocardial infarction [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  • any target lesion revascularization [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  • acute thrombosis [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5 ]
  • sub-acute thrombosis [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5 ]
  • end-stage thrombosis [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5 ]
  • delayed thrombosis [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5 ]


Original Secondary Outcome: Same as current

Information By: ZhuHai Cardionovum Medical Device Co., Ltd.

Dates:
Date Received: October 24, 2016
Date Started: August 2016
Date Completion: June 2022
Last Updated: October 25, 2016
Last Verified: October 2016