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The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

This study has been completed.
Sponsor:
Information provided by:
Pathway Medical Technologies Inc.
ClinicalTrials.gov Identifier:
NCT00676494
First received: May 8, 2008
Last updated: May 18, 2009
Last verified: May 2009
History of Changes
Results First Received: February 23, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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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Reporting Groups
  Description
All Patients Patients meeting eligibility criteria and enrolled in the study.

Baseline Measures
    All Patients  
Number of Participants  
[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
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1.  Primary:   Major Adverse Events (MAEs) Within 30 Days   [ Time Frame: 30 days ]
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2.  Secondary:   Average Rutherford Classification Score at 6 Months   [ Time Frame: 6 months ]
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3.  Secondary:   Average Ankle Brachial Index (ABI) at 6 Months   [ Time Frame: 6 months ]
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4.  Secondary:   Freedom From Target Lesion Revascularization (TLR) at 6 Months   [ Time Frame: 6 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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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


No publications provided by Pathway Medical Technologies Inc.

Publications automatically indexed to this study:


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
Study First Received: May 8, 2008
Results First Received: February 23, 2009
Last Updated: May 18, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices