The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
This study is currently recruiting participants.
Verified June 2012 by Stanford University
Sponsor:
Stanford University
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01406795
First received: July 22, 2011
Last updated: June 6, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Venous Thrombosis |
Device: Gore Viabahn Heparin Coated Stent |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Stent Migration or Stent Fracture [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Stent Migration or Stent Fracture [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Primary patency rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Freedom from device-related amputation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Assisted-primary patency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Secondary patency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Decrease in swelling of affected extremity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Venous Clinical Severity Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- VEINS-QOL [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Villalta PTS Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406795
Contacts
| Contact: Kamil Unver | (650) 725-9810 | kunver@stanfordmed.org |
Locations
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Kamil Unver 650-725-9810 kunver@stanfordmed.org | |
| Principal Investigator: Dr. Lawrence (Rusty) Hofmann MD | |
| Sub-Investigator: Stanley G Rockson | |
| Sub-Investigator: Haruka Itakura | |
| Sub-Investigator: Dr. John D Louie | |
| Sub-Investigator: Gloria Hwang | |
| Sub-Investigator: Nishita N. Kothary | |
| Sub-Investigator: William T Kuo MD | |
| Sub-Investigator: David Hovsepian | |
| Sub-Investigator: Daniel Yung-Ho Sze | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Dr. Lawrence (Rusty) Hofmann MD | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01406795 History of Changes |
| Other Study ID Numbers: | SU-01312011-7377, FDA IDE - G090054, IRB eProtocol - 14781, SPO # 49275 |
| Study First Received: | July 22, 2011 |
| Last Updated: | June 6, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Stanford University:
|
Post Thrombotic Syndrome Venous Stasis Venous Occlusions Venous Stenosis |
Additional relevant MeSH terms:
|
Constriction, Pathologic Thrombosis Venous Thrombosis Venous Thromboembolism Pathological Conditions, Anatomical Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thromboembolism |
Heparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013