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The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses

This study has been terminated.
(Poor enrollment and advances in venoplasty only techniques of the femoral vein)
Sponsor:
Information provided by (Responsible Party):
Lawrence (Rusty) Hofmann, Stanford University
ClinicalTrials.gov Identifier:
NCT01406795
First received: July 22, 2011
Last updated: January 6, 2017
Last verified: January 2017
Results First Received: November 24, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Venous Thrombosis
Intervention: Device: Gore Viabahn Heparin Coated Stent

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study recruited a single patient in 2012 at the Stanford Medical Center. The study ended in 2013.

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
Venous Stent Arm

The study is a single treatment arm study and the venous stent will be placed in all eligible participants.

Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.


Participant Flow:   Overall Study
    Venous Stent Arm
STARTED   1 
COMPLETED   0 
NOT COMPLETED   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.
No text entered.

Reporting Groups
  Description
Venous Stent Arm

The study is a single treatment arm study and the venous stent will be placed in all eligible participants.

Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.


Baseline Measures
   Venous Stent Arm 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      1 100.0% 
Gender 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      1 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Stent Migration   [ Time Frame: up to 1 month following the procedure ]

2.  Primary:   Stent Migration   [ Time Frame: up to one year following the procedure 1 year ]

3.  Primary:   Primary Patency Rate   [ Time Frame: up to 1 year following the procedure ]

4.  Secondary:   Freedom From Device-related Amputation   [ Time Frame: up to 1 year following the procedure ]

5.  Secondary:   Assisted-primary Patency   [ Time Frame: up to 1 year ]

6.  Secondary:   Secondary Patency   [ Time Frame: up to 1 year ]

7.  Secondary:   Adverse Events   [ Time Frame: up to two years 2 years ]

8.  Secondary:   Decrease in Swelling of Affected Extremity   [ Time Frame: up to 2 years ]

9.  Secondary:   Venous Clinical Severity Score   [ Time Frame: up to 2 years ]

10.  Secondary:   VEINS-QOL   [ Time Frame: Up to 2 years ]

11.  Secondary:   Villalta PTS Scale   [ Time Frame: up to 2 years ]


  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
The study was underpowered, enrolling only a single patient (goal enrollment was 15 patients).


  More Information
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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: Rusty Hofmann
Organization: Stanford University
phone: 6507366096
e-mail: lhofmann@stanfordhealthcare.org



Responsible Party: Lawrence (Rusty) Hofmann, Stanford University
ClinicalTrials.gov Identifier: NCT01406795     History of Changes
Other Study ID Numbers: SU-01312011-7377
FDA IDE - G090054
IRB eProtocol - 14781
SPO # 49275
Study First Received: July 22, 2011
Results First Received: November 24, 2016
Last Updated: January 6, 2017