Clinical Trial: BuMA OCT Study(A Comparative Evaluation of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: BuMA OCT Study(A Comparative Evaluation of BuMA Stent and of EXCEL Stent in Terms of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)

Brief Summary:

The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in terms of the extent of neointima formation at 3 months after implantation using OCT.

This is a prospective, single center, randomized, open-label, non-inferiority study, which will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority was met, superiority test will be planned.


Detailed Summary:

About 70 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Fuwai Hospital,will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio).

All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months (including angiographic/OCT investigation), 6 months, 1 and 2 years post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.


Sponsor: Sino Medical Sciences Technology Inc.

Current Primary Outcome: the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment. [ Time Frame: three months after surgery ]

The primary outcome measure is the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Neointimal hyperplasia area/volume [ Time Frame: three months after surgery ]
    It will be measure the neointimal hyperplasia area/volume at 3 months follow-up by OCT assessment.
  • Mean/Minimal Stent diameter/area/volume [ Time Frame: three months after surgery ]
    It will be measure the Mean/Minimal stent diameter/area/volume at 3 months follow-up by OCT assessment.
  • Mean/Minimal Lumen diameter/area/volume [ Time Frame: three months after surgery ]
    It will be measure the Mean/Minimal Lumen diameter/area/volume at 3 months follow-up by OCT assessment.
  • Mean/maximal thickness of the struts coverage [ Time Frame: three months after surgery ]
    It will be measure the Mean/maximal thickness of the struts coverage at 3 months follow-up by OCT assessment.
  • Incomplete strut apposition [ Time Frame: three months after surgery ]
    It will be measure the incomplete strut apposition at 3 months follow-up by OCT assessment.
  • Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months [ Time Frame: three months after surgery ]
  • Late Lumen Loss at 3 months [ Time Frame: three months after surgery ]
  • Binary Restenosis (DS ≥50%) at 3 months [ Time Frame: three months after surgery ]
    All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.
  • Acute success rate [ Time Frame: up to 7 days after surgery ]
    It includes the device success,lesion success and procedural success.
  • Device-oriented Composite Endpoints and its individual components at 3 months [ Time Frame: three months after surgery ]
    Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, Myocardial Infarction(MI) not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
  • Device-oriented Composite Endpoints and its individual components at 6 months [ Time Frame: six months after surgery ]
    Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
  • Device-oriented Composite Endpoints and its individual components at 1 year [ Time Frame: one year after surgery ]
    Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
  • Device-oriented Composite Endpoints and its individual components at 2 years [ Time Frame: 2 years after surgery ]
    Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
  • Stent thrombosis according to the ARC definitions at 3 months [ Time Frame: three months after surgery ]
  • Stent thrombosis according to the ARC definitions at 6 months [ Time Frame: six months after surgery ]
  • Stent thrombosis according to the ARC definitions at 1 year [ Time Frame: one year after surgery ]
  • Stent thrombosis according to the ARC definitions at 2 years [ Time Frame: 2 years after surgery ]


Original Secondary Outcome:

  • Neointimal hyperplasia area/volume [ Time Frame: three months after surgery ]
    It will be measure the neointimal hyperplasia area/volume at 3 months follow-up by OCT assessment.
  • Mean/Minimal Stent diameter/area/volume [ Time Frame: three months after surgery ]
    It will be measure the Mean/Minimal stent diameter/area/volume at 3 months follow-up by OCT assessment.
  • Mean/Minimal Lumen diameter/area/volume [ Time Frame: three months after surgery ]
    It will be measure the Mean/Minimal Lumen diameter/area/volume at 3 months follow-up by OCT assessment.
  • Mean/maximal thickness of the struts coverage [ Time Frame: three months after surgery ]
    It will be measure the Mean/maximal thickness of the struts coverage at 3 months follow-up by OCT assessment.
  • Incomplete strut apposition [ Time Frame: three months after surgery ]
    It will be measure the incomplete strut apposition at 3 months follow-up by OCT assessment.
  • MLD and %DS post procedure and at 3 months [ Time Frame: three months after surgery ]
  • Late Lumen Loss at 3 months [ Time Frame: three months after surgery ]
  • Binary Restenosis (DS ≥50%) at 3 months [ Time Frame: three months after surgery ]
    All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.
  • Acute success rate [ Time Frame: up to 7 days after surgery ]
    It includes the device success,lesion success and procedural success.
  • Device-oriented Composite Endpoints and its individual components at 3 months [ Time Frame: three months after surgery ]
    Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
  • Device-oriented Composite Endpoints and its individual components at 6 months [ Time Frame: six months after surgery ]
    Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
  • Device-oriented Composite Endpoints and its individual components at 1 year [ Time Frame: one year after surgery ]
    Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
  • Device-oriented Composite Endpoints and its individual components at 2 years [ Time Frame: 2 years after surgery ]
    Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
  • Stent thrombosis according to the ARC definitions at 3 months [ Time Frame: three months after surgery ]
  • Stent thrombosis according to the ARC definitions at 6 months [ Time Frame: six months after surgery ]
  • Stent thrombosis according to the ARC definitions at 1 year [ Time Frame: one year after surgery ]
  • Stent thrombosis according to the ARC definitions at 2 years [ Time Frame: 2 years after surgery ]


Information By: Sino Medical Sciences Technology Inc.

Dates:
Date Received: December 7, 2012
Date Started: December 2012
Date Completion:
Last Updated: March 10, 2016
Last Verified: March 2016