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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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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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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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

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

Other Adverse Events
    BridgePoint Medical System  
Total, other (not including serious) adverse events    
# participants affected / at risk     61/147  
Cardiac disorders    
Cardiac Enzyme Elevation [1]  
# participants affected / at risk     21/147 (14.29%)  
# events     21  
Vascular disorders    
Untreated Dissection    
# participants affected / at risk     1/147 (0.68%)  
# events     1  
Puncture Site Complication    
# participants affected / at risk     11/147 (7.48%)  
# events     11  
Non-Target Vessel Treatment    
# participants affected / at risk     3/147 (2.04%)  
# events     3  
Other [2]  
# participants affected / at risk     25/147 (17.01%)  
# events     25  
[1] Enzyme elevation that did not fit the definition of NQWMI
[2] Includes but not limited to: chest pain, hypotension, radiation burn, pulmonary embolism, dermatitis, vomiting, vasovagal reaction, and heart murmur.



  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
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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