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Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BridgePoint Medical
ClinicalTrials.gov Identifier:
NCT00886899
First received: April 21, 2009
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
Results First Received: February 21, 2012  
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 Chronic Total Occlusion
Intervention: Device: Recanalization of a coronary chronic total occlusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BridgePoint Medical System Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire

Participant Flow:   Overall Study
    BridgePoint Medical System  
STARTED     147  
COMPLETED     147  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
BridgePoint Medical System Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire

Baseline Measures
    BridgePoint Medical System  
Number of Participants  
[units: participants]
 		  147  
Age  
[units: years]
Mean ± Standard Deviation 		  63.3  ± 9.1  
Gender  
[units: participants]
 		 
Female     20  
Male     127  
Region of Enrollment  
[units: participants]
 		 
United States     147  



  Outcome Measures
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1.  Primary:   Technical Success   [ Time Frame: Intraprocedural ]
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Measure Type Primary
Measure Title Technical Success
Measure Description Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire
Time Frame Intraprocedural  
Safety Issue No  

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.
Three participants had two CTOs, so there were a total of 150 CTOs in 147 participants.

Reporting Groups
  Description
BridgePoint Medical System Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire

Measured Values
    BridgePoint Medical System  
Number of Participants Analyzed  
[units: participants]
 		  147  
Number of CTOs Analyzed  
[units: CTOs]
 		  150  
Technical Success  
[units: percentage of CTOs]
Number ( 90% Confidence Interval ) 		  77  
  ( 70 to 82 )  

No statistical analysis provided for Technical Success



2.  Primary:   30-day Major Adverse Cardiac Event (MACE) Rate   [ Time Frame: 30 Days ]
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3.  Secondary:   Total Procedure Time   [ Time Frame: Intraprocedural ]
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4.  Secondary:   Total Procedural Fluoroscopy Time   [ Time Frame: Intraprocedural ]
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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 NOT 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: VP, Clinical Affairs
Organization: BridgePoint Medical
phone: 763-225-8500
e-mail: jschultz@bridgepointmedical.com


No publications provided by BridgePoint Medical

Publications automatically indexed to this study:


Responsible Party: BridgePoint Medical
ClinicalTrials.gov Identifier: NCT00886899     History of Changes
Other Study ID Numbers: 200-0002
Study First Received: April 21, 2009
Results First Received: February 21, 2012
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration