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

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.
ClinicalTrials.gov Identifier: NCT01412164
Recruitment Status : Active, not recruiting
First Posted : August 9, 2011
Results First Posted : March 17, 2016
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Device: FIREHAWK biodegradable polymer rapamycin-eluting stent

  Participant Flow

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

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.
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


Baseline Measures
   Firehawk 
Overall Participants Analyzed 
[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.  


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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
First Submitted: August 5, 2011
First Posted: August 9, 2011
Results First Submitted: February 19, 2016
Results First Posted: March 17, 2016
Last Update Posted: March 17, 2016