Venous Thrombosis
Conditions
Keywords
Post Thrombotic Syndrome, Venous Stasis, Venous Occlusions, Venous Stenosis
Brief summary
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.
Interventions
DEVICEGore 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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is at least 18 years old * Patient has clinical manifestations (i.e. symptoms and/or signs) of chronic DVT of an extremity. The Venous Clinical Severity Score (VCSS) will be used to determine if the patient is currently suffering from chronic DVT, with a VCSS score of 4 or greater necessary for inclusion. * Imaging confirmation of venous occlusion or stenosis (\>50%) involving the femoral, and/or popliteal veins * Obstructed vessel caliber can accommodate a 7FR System, from insertion site to target segment * Patient is able to read and answer a questionnaire in English
Exclusion criteria
* History of life-threatening reaction to contrast material * Unwilling or unable to provide informed consent, or return for required follow-up evaluations * Participating in another investigational study that has not completed follow-up testing * Cannot receive outpatient anticoagulation such as LMWH and/or vitamin K antagonists (VKAs) * Absolute contraindication to contrast media or renal insufficiency (baseline creatinine \>2.0 mg/dL). * Either a history or presence of heparin-induced thrombocytopenia antibodies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent Migration | 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. |
| Primary Patency Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Patency | 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 | 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 | up to 2 years | The count of participants that experienced a decrease in swelling after the stent was placed. |
| Freedom From Device-related Amputation | 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. |
| VEINS-QOL | 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 | 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. |
| Venous Clinical Severity Score | 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. |
| Assisted-primary Patency | 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. |
Countries
United States
Participant flow
Recruitment details
The study recruited a single patient in 2012 at the Stanford Medical Center. The study ended in 2013.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Venous Stent Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Gender Female | 0 Participants |
| Gender Male | 1 Participants |
| Region of Enrollment United States | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: up to 1 year following the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venous Stent Arm | Primary Patency Rate | 1 Participants |
Primary
Stent Migration
Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.
Time frame: up to 1 month following the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venous Stent Arm | Stent Migration | 0 Participants |
Primary
Stent Migration
Stent migration is reported as the count of participants with stent migration within 1 year following stent placement.
Time frame: up to one year following the procedure 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venous Stent Arm | Stent Migration | 0 Participants |
Secondary
Adverse Events
Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure.
Time frame: up to two years 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venous Stent Arm | Adverse Events | 0 Participants |
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.
Time frame: up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venous Stent Arm | Assisted-primary Patency | 0 Participants |
Secondary
Decrease in Swelling of Affected Extremity
The count of participants that experienced a decrease in swelling after the stent was placed.
Time frame: up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venous Stent Arm | Decrease in Swelling of Affected Extremity | 0 Participants |
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.
Time frame: up to 1 year following the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venous Stent Arm | Freedom From Device-related Amputation | 1 Participants |
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.
Time frame: up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venous Stent Arm | Secondary Patency | 0 Participants |
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.
Time frame: Up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venous Stent Arm | VEINS-QOL | 1 Participants |
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.
Time frame: up to 2 years
Population: Data were not collected for this outcome
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.
Time frame: up to 2 years
Population: Data were not collected for this outcome.