Effect of TCFA on Neointimal Coverage After PCI at 9 Months Follow-up
Condition: Unrecognized Condition
Study type: Observational

Summary: 
      Although drug-eluting stents have reduced rates of restenosis and late lumen loss compared
      with bare metal stents, late stent thrombosis (LST), a life-threatening complication of this
      technology, has emerged as a major concern. Researches indicated incomplete neointimal
      coverage of stent struts as the most important morphometric predictor of LST. Pathological
      research showed stenting disruption of adjacent vulnerable plaques can precipitate LST,
      Meanwhile, thin-cap fibroatheromas (TCFA) as the most important predictor of Major Adverse
      Cardiovascular. Therefore, there is a hypothesis that TCFA may impair intimal healing which
      are prone to LST in vivo.

      Optical coherence tomography (OCT)is a high-resolution (<10 µm), catheter-based imaging
      modality capable of investigating detailed coronary plaque morphology in vivo.This study
      aimed to observe that TCFA will arise what of the effect on intimal healing of stent struts
      on the lesions which fractional flow reserve (FFR)≤0.75 after EXCEL biodegradable
      polymer-coated sirolimus-eluting stent was implanted at 9 months follow up: evaluated by OCT
      and FFR
    

Detailed description: 
      The primary end point is to Neointimal coverage after 9 months of the stent implantation.

      Quality assurance plan that addresses data validation and registry procedures, including any
      plans for site monitoring and auditing.

      Data checks to compare data entered into the registry against predefined rules for range or
      consistency with other data fields in the registry.

      Source data verification to assess the accuracy, completeness, or representativeness of
      registry data by comparing the data to external data sources (e.g., medical records, paper or
      electronic case report forms, or interactive voice response systems).

      Data dictionary that contains detailed descriptions of each variable used by the registry,
      including the source of the variable, coding information if used and normal ranges if
      relevant.

      Standard Operating Procedures to address registry operations and analysis activities, such as
      patient recruitment, data collection, data management, data analysis, reporting for adverse
      events, and change management.

      Sample size assessment to specify the number of participants or participant years necessary
      to demonstrate an effect.
    

Intervention name(s): EXCEL biodegradable polymer-coated sirolimus-eluting stent
Intervention type(s): Device
Intervention MeSH terms: Sirolimus
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study will plan for a total of 55 patients with Non ST-ACS (all of the patients was
        selected in different blood vessels, a total of up to two target disease Variable and each
        target lesion 1 stents, such as placing stents need more than one in the operation, require
        the use of EXCEL stents, mix does not recommend the same patients Other brand support,
        unless save extra stents.) Choose lesions reference diameter of 2.5 mm to 4.0 mm (visual),
        each lesion length 32 mm or less (visual), participants must conform to the standard can be
        selected.
      
Keywords: national Cather Lad; Interventional Imaging Training Base