EXCEL-II Stent Vesus EXCEL Stent to Treat the Patients With de Novo Coronary Artery Lesions.
Condition: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this Randomized Study to evaluate the safety and efficacy of the Excel-II DES
      compared to the EXCEL DES in the treatment of patients with de novo coronary artery lesions.
    

Detailed description: 
      The primary end point is to observe in-stent late lumenn loss after 9 months of the stent
      implantation.

      This study is based on non-inferior assumption (vs. EXCEL-II V EXCEL Stent), requring all of
      end points reach statictic significance.

      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.

      Plan for missing data to address situations where variables are reported as missing,
      unavailable, "non-reported," uninterpretable, or considered missing because of data
      inconsistency or out-of-range results Statistical analysis plan describing the analytical
      principles and statistical techniques to be employed in order to address the primary and
      secondary objectives, as specified in the study protocol or plan.
    

Intervention name(s): EXCEL DES implatation; EXCEL-II DES implantation
Intervention type(s): Procedure; Procedure
Intervention description(s): Implant DES for CAD cases; Implant DES for CAD cases
Other intervention name(s): Implant DES for CAD cases; Implant EXCEL-II DES for CAD cases
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study will plan for a total of 416 patients with primary, in situ coronary artery
        lesions (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 the same brand of stents, mix does not
        recommend the same patients Other brand support, unless save extra stents.) Choose lesions
        reference diameter of 2.5 mm to 2.5 mm (visual), each lesion length 32 mm or less (visual),
        participants must conform to the standard can be selected.
      
Biospecimen description: 
      Endpoint Classification: Safety/Efficacy Study Enrollment: 416 cases [Anticipated]
    
Keywords: Late Lumen Loss; MACE; Death; TLF; Thrombosis(definite or probable )