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The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676494
First Posted: May 13, 2008
Last Update Posted: July 9, 2009
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.
Information provided by:
Pathway Medical Technologies Inc.
Results First Submitted: February 23, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Peripheral Artery Disease
Intervention: Device: Pathway PV 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
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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
All Patients Patients meeting eligibility criteria and enrolled in the study.

Participant Flow:   Overall Study
    All Patients
STARTED   172 
COMPLETED   158 
NOT COMPLETED   14 
Missed Visit                8 
Withdrawal by Subject                6 



  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
All Patients Patients meeting eligibility criteria and enrolled in the study.

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[Units: Participants]
 172 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   38 
>=65 years   134 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.9  (8.4) 
Gender 
[Units: Participants]
 
Female   88 
Male   84 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Major Adverse Events (MAEs) Within 30 Days   [ Time Frame: 30 days ]

2.  Secondary:   Average Rutherford Classification Score at 6 Months   [ Time Frame: 6 months ]

3.  Secondary:   Average Ankle Brachial Index (ABI) at 6 Months   [ Time Frame: 6 months ]

4.  Secondary:   Freedom From Target Lesion Revascularization (TLR) at 6 Months   [ Time Frame: 6 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: Kevin Peters/Director of Clinical Affairs
Organization: Pathway Medical Technologies, Inc.
phone: 425-636-4053
e-mail: petersk@pathwaymedical.com


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

Responsible Party: Kevin Peters, Director of Clinical Affairs, Pathway Medical Technologies Inc.
ClinicalTrials.gov Identifier: NCT00676494     History of Changes
Other Study ID Numbers: PTC 05003
First Submitted: May 8, 2008
First Posted: May 13, 2008
Results First Submitted: February 23, 2009
Results First Posted: July 9, 2009
Last Update Posted: July 9, 2009