Venous ThrombosisNCT01406795
The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
A study testing Gore Viabahn Heparin Coated Stent in people with Venous Thrombosis, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Gore Viabahn Heparin Coated Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses
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.
- Conditions
- Venous Thrombosis
- Being tested
- Gore Viabahn Heparin Coated Stent
- Keywords
- Post Thrombotic Syndrome, Venous Stasis, Venous Occlusions, Venous Stenosis
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gore Viabahn Heparin Coated StentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Venous Stent Arm | Experimental | The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Receives: Device: Gore Viabahn Heparin Coated Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent Migration
Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.
Measured: 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.
Measured: 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.
Measured: up to 1 year following the procedure
Secondary outcomes (8)
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.
Measured: up to 1 year following the procedure
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Poor enrollment and advances in venoplasty only techniques of the femoral vein
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence (Rusty) Hofmann, Stanford University
- Investigators
- Dr. Lawrence (Rusty) Hofmann MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406795
- Sponsor's protocol ID
- SU-01312011-7377
- Other IDs
- FDA IDE - G090054, IRB eProtocol - 14781, SPO # 49275
- Status last verified
- Jan 2017
- First submitted
- 22 Jul 2011
- Last updated
- 27 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses
- ClinicalTrials.gov ID
- NCT01406795
- Acronym / sponsor ID
- SU-01312011-7377
- Conditions
- Venous Thrombosis
- Keywords
- Post Thrombotic Syndrome, Venous Stasis, Venous Occlusions, Venous Stenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment and advances in venoplasty only techniques of the femoral vein
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Posted 27 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venous Stent Arm | Experimental | Device: Gore Viabahn Heparin Coated StentThe study is a single treatment arm study and the venous stent will be placed in all eligible participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gore Viabahn Heparin Coated StentFor 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. | Device | Venous Stent Arm |
Primary outcome
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.
8 secondary outcomes
Freedom From Device-related Amputation
Time frame: up to 1 year following the procedure
Assisted-primary Patency
Time frame: up to 1 year
Secondary Patency
Time frame: up to 1 year
Adverse Events
Time frame: up to two years 2 years
Decrease in Swelling of Affected Extremity
Time frame: up to 2 years
Venous Clinical Severity Score
Time frame: up to 2 years
VEINS-QOL
Time frame: Up to 2 years
Villalta PTS Scale
Time frame: up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Lawrence (Rusty) Hofmann MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gore Viabahn Heparin Coated Stent in people with Venous Thrombosis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent Migration (time frame: up to 1 month following the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.