Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II (CONNECTII)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avinger, Inc.
ClinicalTrials.gov Identifier:
NCT01537302
First received: February 15, 2012
Last updated: March 17, 2015
Last verified: March 2015
Results First Received: March 5, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Total Atherosclerotic Occlusion of Femoral Artery
Intervention: Device: CTO crossing in femoropopliteal arteries CONNECT II

  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
Treatment Arm CTO crossing in femoropopliteal arteries using the Ocelot System

Participant Flow:   Overall Study
    Treatment Arm  
STARTED     201  
COMPLETED     199  
NOT COMPLETED     2  
Lost to Follow-up                 1  
Withdrawal by Subject                 1  



  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.
All enrolled subjects.

Reporting Groups
  Description
Ocelot CTO crossing in femoropopliteal arteries using the Ocelot System

Baseline Measures
    Ocelot  
Number of Participants  
[units: participants]
  201  
Age  
[units: years]
Mean (Standard Deviation)
  68.9  (9.4)  
Gender  
[units: participants]
 
Female     101  
Male     100  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     133  
African American     45  
Hispanic/Latino     7  
Asian     1  
American Indian     0  
Native Hawaiian or Pacific Islander     1  
Other     2  
Not Captured     12  
Region of Enrollment  
[units: participants]
 
United States     182  
Germany     13  
Italy     6  
Rutherford  
[units: participants]
 
0 - Asymptomatic     0  
1 - Mild Claudication     0  
2 - Moderate Claudication     34  
3 - Severe Claudication     119  
4 - Ischemic Rest Pain     34  
5 - Minor Tissue Loss     14  
6 - Major Tissue Loss     0  
Ankle-Brachial Index  
[units: participants]
 
ABI >1.3: Non-Compressible Vessels     1  
ABI ≥ 0.95: Normal     9  
ABI < 0.95: Peripheral Vascular Disease     91  
ABI < 0.6: Intermittent Claudication     79  
ABI < 0.4: Chronic Limb Ischemia     16  
ABI Unobtainable     5  
Body Mass Index  
[units: kg/m2]
Mean (Standard Deviation)
  28.2  (5.9)  



  Outcome Measures
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1.  Primary:   Primary Safety Endpoint   [ Time Frame: Day 30 ]

2.  Primary:   Primary Efficacy Endpoint   [ Time Frame: Day 0 ]

3.  Secondary:   Procedural Success   [ Time Frame: Day 0 ]

4.  Secondary:   Technical Success   [ Time Frame: Day 0 ]

5.  Secondary:   Device Performance   [ Time Frame: Day 0 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Procedural Times   [ Time Frame: Day 0 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Fluoroscopic Times   [ Time Frame: Day 0 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Crossing Times   [ Time Frame: Day 0 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Use of Assist Devices   [ Time Frame: Day 0 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Contrast/Flush Volumes   [ Time Frame: Day 0 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Matthew Selmon, MD
Organization: Austin Heart
phone: 512-788-2692
e-mail: matthew.selmon@hcahealthcare.com


No publications provided


Responsible Party: Avinger, Inc.
ClinicalTrials.gov Identifier: NCT01537302     History of Changes
Other Study ID Numbers: AVI OCT 10005
Study First Received: February 15, 2012
Results First Received: March 5, 2015
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Italy: Ethics Committee