Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shanghai MicroPort Medical (Group) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01412164
First received: August 5, 2011
Last updated: February 19, 2016
Last verified: February 2016
Results First Received: February 19, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Device: FIREHAWK biodegradable polymer rapamycin-eluting stent

  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
Firehawk

Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD

FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD


Participant Flow:   Overall Study
    Firehawk  
STARTED     730  
COMPLETED     712  
NOT COMPLETED     18  



  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
Firehawk

Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD

FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD


Baseline Measures
    Firehawk  
Number of Participants  
[units: participants]
  730  
Age  
[units: years]
Mean (Standard Deviation)
  58.71  (8.90)  
Gender  
[units: participants]
 
Female     213  
Male     517  
Region of Enrollment  
[units: participants]
 
China     730  



  Outcome Measures

1.  Primary:   Device Related Cardiovascular Composite Endpoint   [ Time Frame: 12 months ]

2.  Secondary:   Stent Implantation Success Rate   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
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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.


Results Point of Contact:  
Name/Title: Kefei Li
Organization: Shanghai Microport Medical (Group) Co.,Ltd.
phone: +86-21-38954600×6700
e-mail: kfli@microport.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shanghai MicroPort Medical (Group) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01412164     History of Changes
Other Study ID Numbers: TARGET II
Study First Received: August 5, 2011
Results First Received: February 19, 2016
Last Updated: February 19, 2016
Health Authority: China: Food and Drug Administration