Sprinter Legend Balloon Catheter

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00961311
First received: July 14, 2009
Last updated: October 21, 2011
Last verified: October 2011
Results First Received: January 27, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Procedure: Percutaneous Coronary Intervention
Device: Sprinter Legend 1.25mm Balloon Catheter

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Balloon Angioplasty All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.

Baseline Measures
    Balloon Angioplasty  
Number of Participants  
[units: participants]
  51  
Age  
[units: years]
Mean ± Standard Deviation
  67  ± 10  
Gender  
[units: participants]
 
Female     5  
Male     46  
Region of Enrollment  
[units: participants]
 
United States     51  



  Outcome Measures
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1.  Primary:   Procedural Success   [ Time Frame: 1-3 days ]

2.  Secondary:   Major Adverse Cardic Events (MACE)   [ Time Frame: 1-3 days ]

3.  Secondary:   Vessel Perforation (Clinical)   [ Time Frame: 1-3 days ]

4.  Secondary:   Device Success   [ Time Frame: 1-3 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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