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Sprinter Legend Balloon Catheter

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00961311
First Posted: August 18, 2009
Last Update Posted: October 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Vascular
Results First Submitted: January 27, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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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  More Information