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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
History of Changes
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
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  Baseline Characteristics
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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 ]
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2.  Secondary:   Major Adverse Cardic Events (MACE)   [ Time Frame: 1-3 days ]
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3.  Secondary:   Vessel Perforation (Clinical)   [ Time Frame: 1-3 days ]
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4.  Secondary:   Device Success   [ Time Frame: 1-3 days ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: K. Bogdanovich
Organization: Medtronic Cardiovascular
e-mail: rs.medtroniccardiovascularclinicaltrials@medtronic.com


Publications of Results:


Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00961311     History of Changes
Other Study ID Numbers: IP-111
Study First Received: July 14, 2009
Results First Received: January 27, 2011
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration