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Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc
ClinicalTrials.gov Identifier:
NCT01092416
First received: March 23, 2010
Last updated: August 10, 2016
Last verified: August 2016
Results First Received: September 1, 2015  
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: Diamondback 360 Orbital Atherectomy System

  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
The study received approval to enroll up to 429 subjects. Following the introduction of the Electric OAS, the enrollment was expanded to a maximum of 479 subjects, to enroll 100 subjects with the Electric OAS. A total of 443 subjects were enrolled in the study between May 25, 2010 and November 26, 2012 at 49 U.S. study sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A subject was considered enrolled when a signed informed consent was in place, all inclusion/no exclusion criteria were met, and the study guidewire had crossed the target lesion.

Reporting Groups
  Description
ORBIT II Subjects Subjects enrolled in ORBIT II study.

Participant Flow for 3 periods

Period 1:   Enrollment
    ORBIT II Subjects
STARTED   443 
COMPLETED   440 
NOT COMPLETED   3 
Atherectomy device not inserted                3 

Period 2:   30-Day Follow-up
    ORBIT II Subjects
STARTED   440 
COMPLETED   430 
NOT COMPLETED   10 
Death                2 
Missed 30-day follow-up                3 
Data collected after close of 30D window                5 

Period 3:   12-Month Follow-up
    ORBIT II Subjects
STARTED   438 
COMPLETED   413 
NOT COMPLETED   25 
Death                16 
Lost to Follow-up                4 
Withdrawal by Subject                2 
Missed 1-year follow-up                1 
Data collected after close of 1Y window                2 



  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
ORBIT II Subjects Subjects enrolled in ORBIT II study.

Baseline Measures
   ORBIT II Subjects 
Overall Participants Analyzed 
[Units: Participants]
 443 
Age 
[Units: Years]
Mean (Full Range)
 71.4 
 (37.4 to 92.2) 
Gender 
[Units: Participants]
 
Female   157 
Male   286 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   390 
Black or African American   25 
Asian   9 
Hispanic or Latino   15 
Native American   1 
Other   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)   [ Time Frame: 30 days ]

2.  Primary:   Primary Efficacy Endpoint: Procedural Success   [ Time Frame: Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours. ]

3.  Secondary:   Angiographic Success   [ Time Frame: Baseline procedure, with a mean total procedure time of 52.5 minutes. ]

4.  Secondary:   Severe Angiographic Complications   [ Time Frame: Baseline procedure, with a mean total procedure time of 52.5 minutes. ]

5.  Secondary:   12-Month Freedom From Major Adverse Cardiac Events (MACE)   [ Time Frame: 12 months ]


  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 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.


Results Point of Contact:  
Name/Title: Clinical Project Manager
Organization: Cardiovascular Systems, Inc.
phone: 6512591600
e-mail: clinicaltrials_csi@csi360.com


Publications of Results:

Responsible Party: Cardiovascular Systems Inc
ClinicalTrials.gov Identifier: NCT01092416     History of Changes
Other Study ID Numbers: ORBIT II
Study First Received: March 23, 2010
Results First Received: September 1, 2015
Last Updated: August 10, 2016
Health Authority: United States: Food and Drug Administration