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