The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
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|ClinicalTrials.gov Identifier: NCT01406795|
Recruitment Status : Terminated (Poor enrollment and advances in venoplasty only techniques of the femoral vein)
First Posted : August 1, 2011
Results First Posted : February 27, 2017
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Venous Thrombosis||Device: Gore Viabahn Heparin Coated Stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Venous Stent Arm
The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Device: 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.
- Stent Migration [ Time Frame: up to 1 month following the procedure ]Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.
- Stent Migration [ Time Frame: up to one year following the procedure 1 year ]Stent migration is reported as the count of participants with stent migration within 1 year following stent placement.
- Primary Patency Rate [ Time Frame: up to 1 year following the procedure ]Patency refers to whether the stent is unoccluded (open). Primary patency rate was defined as the count of participants with >= 50% patency following initial stent placement, and is reported as the count of participants meeting this criteria.
- Freedom From Device-related Amputation [ Time Frame: up to 1 year following the procedure ]Freedom from device-related amputation (amputation of infected limb) is reported as the count of participants with no device-related amputation within 1 year following stent placement.
- Assisted-primary Patency [ Time Frame: up to 1 year ]Patency refers to whether the stent is unoccluded (open). Primary refers to the first time a stent was placed (or the first time patency needed to be established). Assisted refers to the fact that a device (like a balloon) was used to open the stent. Assisted-primary patency is defined as the count of participants that demonstrated the need for an intervention to establish patency.
- Secondary Patency [ Time Frame: up to 1 year ]Secondary patency means that the initial intervention failed and a second intervention was performed to establish or maintain patency. Secondary patency is defined as the count of participants that required a second intervention to establish patency.
- Adverse Events [ Time Frame: up to two years 2 years ]Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure.
- Decrease in Swelling of Affected Extremity [ Time Frame: up to 2 years ]The count of participants that experienced a decrease in swelling after the stent was placed.
- Venous Clinical Severity Score [ Time Frame: up to 2 years ]Venous Clinical Severity represents the severity of the venous pathology, which includes measures like pain, inflammation, and number of ulcers. It is scored on a scale of 0-3 with the upper end representing very severe outcomes for the patient.
- VEINS-QOL [ Time Frame: Up to 2 years ]The VEINS-QOL is a questionnaire that represents a patient's quality of life, using measures like how well the patient can walk, sleep, and enjoy life. Responses are graded on a scale of 1-5, with 1 being very good, and 5 being very poor. The VEINS-QOL measure is defined by the count of participants that showed a decreased overall score following their procedure.
- Villalta PTS Scale [ Time Frame: up to 2 years ]The Villalta PTS Scale is a score based on the patient's symptoms, includes cramps, pain, and redness. It is scaled from 0 to 48, with a higher score representing more severe disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406795
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Dr. Lawrence (Rusty) Hofmann MD||Stanford University|