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| ID | Type | Description | Link |
|---|---|---|---|
| FDA IDE - G090054 | |||
| IRB eProtocol - 14781 | |||
| SPO # 49275 |
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Poor enrollment and advances in venoplasty only techniques of the femoral vein
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To study the safety and efficacy of drug coated stents for the treatment of venous occlusions and stenoses in the lower extremity. The use of the device for the treatment of peripheral arterial disease is approved by the FDA, however, the use of the device in venous occlusions and stenoses, although performed by some practitioners, has not yet been studied in detail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venous Stent Arm | Experimental | The study is a single treatment arm study and the venous stent will be placed in all eligible participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gore Viabahn Heparin Coated Stent | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Migration | Stent migration is reported as the count of participants with stent migration within 1 month following stent placement. | up to 1 month following the procedure |
| Stent Migration | Stent migration is reported as the count of participants with stent migration within 1 year following stent placement. | up to one year following the procedure 1 year |
| Primary Patency Rate | 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. | up to 1 year following the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Device-related Amputation | 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. | up to 1 year following the procedure |
| Assisted-primary Patency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Lawrence (Rusty) Hofmann MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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The study recruited a single patient in 2012 at the Stanford Medical Center. The study ended in 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stent Migration | Stent migration is reported as the count of participants with stent migration within 1 month following stent placement. | Posted | Count of Participants | Participants | up to 1 month following the procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The study was underpowered, enrolling only a single patient (goal enrollment was 15 patients).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rusty Hofmann | Stanford University | 6507366096 | lhofmann@stanfordhealthcare.org |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D054070 | Postthrombotic Syndrome |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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. |
| up to 1 year |
| Secondary Patency | 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. | up to 1 year |
| Adverse Events | Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure. | up to two years 2 years |
| Decrease in Swelling of Affected Extremity | The count of participants that experienced a decrease in swelling after the stent was placed. | up to 2 years |
| Venous Clinical Severity Score | 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. | up to 2 years |
| VEINS-QOL | 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. | Up to 2 years |
| Villalta PTS Scale | 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. | up to 2 years |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Stent Migration | Stent migration is reported as the count of participants with stent migration within 1 year following stent placement. | Posted | Count of Participants | Participants | up to one year following the procedure 1 year |
|
|
|
| Primary | Primary Patency Rate | 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. | Posted | Count of Participants | Participants | up to 1 year following the procedure |
|
|
|
| Secondary | Freedom From Device-related Amputation | 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. | Posted | Count of Participants | Participants | up to 1 year following the procedure |
|
|
|
| Secondary | Assisted-primary Patency | 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. | Posted | Count of Participants | Participants | up to 1 year |
|
|
|
| Secondary | Secondary Patency | 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. | Posted | Count of Participants | Participants | up to 1 year |
|
|
|
| Secondary | Adverse Events | Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure. | Posted | Count of Participants | Participants | up to two years 2 years |
|
|
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| Secondary | Decrease in Swelling of Affected Extremity | The count of participants that experienced a decrease in swelling after the stent was placed. | Posted | Count of Participants | Participants | up to 2 years |
|
|
|
| Secondary | Venous Clinical Severity Score | 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. | Data were not collected for this outcome | Posted | up to 2 years |
|
|
| Secondary | VEINS-QOL | 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. | Posted | Count of Participants | Participants | Up to 2 years |
|
|
|
| Secondary | Villalta PTS Scale | 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. | Data were not collected for this outcome. | Posted | up to 2 years |
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| 0 |
| 1 |
| 0 |
| 1 |
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| D014689 |
| Venous Insufficiency |
| D014648 | Varicose Veins |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |