Clinical Trial: A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation Using OCT

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

Official Title: A Prospective, Multicenter, Randomized Comparative Evaluation of BuMA Supreme Stent and of Xience Stent in Terms of the Extent of Neointimal Formation at 1 Month and 2 Months Via OCT After Implantatio

Brief Summary: The objective of this study is a comparative evaluation of BuMA Supreme™ stent and of Xience V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after implanting in relatively high bleeding risk patients with coronary artery disease using OCT.

Detailed Summary:

This is a prospective, multicenter, randomized, non-inferiority study, which will enroll a total of 80 subjects from approximately 8 centers. All subjects will be firstly randomly assigned to 1st month OCT (40 pts) or 2nd month OCT group(40 pts). Then both two groups will be randomly assigned to undergoing implantation of BuMA Supreme™ stent (20 pts) or Xience V/Prime stent (20 pts). If non-inferiority was met, superiority test will be planned.

All of the patients be followed up to 2 years. The follow-up visits will be conducted at 1 or 2 months (including QCA/OCT investigation), 3 months, 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 1 or 2 months follow-up by OCT assessment. [ Time Frame: 1 or 2 months ]

1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Neointimal hyperplasia area/volume [ Time Frame: 1 or 2 months ]
    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
  • Mean/Minimal Stent diameter/area/volume [ Time Frame: 1 or 2 months ]
    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
  • Mean/Minimal Lumen diameter/area/volume [ Time Frame: 1 or 2 months ]
    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
  • Mean/maximal thickness of the struts coverage [ Time Frame: 1 or 2 months ]
    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
  • Incomplete strut apposition [ Time Frame: 1 or 2 months ]
    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
  • Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months [ Time Frame: 1 or 2 months ]
    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
  • Late Lumen Loss [ Time Frame: 1 or 2 month ]
    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
  • Binary Restenosis (DS ≥50%) [ Time Frame: 1 or 2 months ]
    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 ]
    It includes the device success,lesion success and procedural success.
  • Device-oriented Composite Endpoints and its individual components [ Time Frame: 1 or 2, 3, 6 months, 1 year, 2 years ]
    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.
  • Stent thrombosis according to the ARC definitions [ Time Frame: 1 or 2, 3, 6 months, 1 year, 2 years ]
    Definite and probable stent thrombosis during acute, subacute, later and very late phase.
  • bleeding events [ Time Frame: 1 or 2, 3, 6 months, 1 year, 2 years ]


Original Secondary Outcome: Same as current

Information By: Sino Medical Sciences Technology Inc.

Dates:
Date Received: April 18, 2016
Date Started: June 2016
Date Completion: October 2018
Last Updated: August 12, 2016
Last Verified: August 2016