Clinical Study Sponsor: BTG International 016 – Vanish Study (Bellevue only)
Type of Study: Varicose Vein (VV) – (visible, symptomatic, medially located)
Study Closed: November, 2014
To evaluate the efficacy and safety of Varisolve™ PEM 0.5% and 1% compared to Agitated Saline and compared to Varisolve™ PEM 0.125% in patients with SFJ incompetence due to reflux of the great saphenous vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities.
Clinical Study Sponsor: Gore Revise Study
Type of Study: Device (stent) study
Study Closed: November, 2014
To establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.
Clinical Study Sponsor: Claudication Assessment Tool (CAT)
Type of Study: Survey Study
Study Closed: January, 2013
The purpose of this study is to evaluate the effects of an investigational blood thinner, Apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE).
Clinical Study Sponsor: University of Washington/Sigvaris/COSSCA
Type of Study: Varicose Vein
Study Closed: January, 2013
To compare specialized versus standard compression stockings after saphenous ablation.
Clinical Study Sponsor: Hollister
Type of Study: Venous Leg Ulcer
Study Closed: November, 2012
Restore calcium alginate silver vs. aqua silver wound dressing.
Clinical Study Sponsor: Pfizer 056/i3 Research (with OHMC) / Apixaban (“Acute study”)
Type of Study: Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
Study Closed: August, 2012
The purpose of this study is to evaluate the effects of an investigational blood thinner, Apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE).
Clinical Study Sponsor: Boehringer Ingelheim RE-SONATE (with OHMC)
Type of Study: DVT/PE
Study Closed: May, 2012
Long-Term Prevention of Recurrent Symptomatic Venous Thromboembolism.
Publications based on the results of this research:
- New England Journal of Medicine article, “Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism”
Clinical Study Sponsor: BTG International 015 — Vanish Study (Kirkland only)
Type of Study: Varicose Vein (VV) – (visible, symptomatic, medially located)
Study Closed:
To evaluate the efficacy and safety of Varisolve™ PEM 0.5% and 1% compared to Agitated Saline and compared to Varisolve™ PEM 0.125% in patients with SFJ incompetence due to reflux of the great saphenous vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities.
Clinical Study Sponsor: Pfizer EXT 057/i3 Research / Apixaban (“Chronic study”)
Type of Study: Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE), completed 6-12 months of anticoagulant Rx.
Study Closed: July, 2011
The purpose is to evaluate the effects of an investigational blood thinner, Apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE).
Publications based on the results of this research:
- New England Journal of Medicine article, “Apixaban for Extended Treatment of Venous Thromboembolism”
Clinical Study Sponsor: BTG International 017: Endovenous Thermal Ablation with or without Varisolve PEM
Type of Study: Varicose Vein
Study Closed: May, 2011
To evaluate the safety and effectiveness of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.
Publications based on the results of this research:
- BTG International press release, “Full data from pivotal Phase III trials of Varisolve® PEM presented at the 26th Annual Congress of the American College of Phlebology”
Clinical Study Sponsor: Healthpoint 015
Type of Study: Venous leg ulcer
Study Closed: January, 2011
A 16-week study for subjects with a venous leg ulcer between the knee and ankle.
Clinical Study Sponsor: Healthpoint 016
Type of Study: Venous leg ulcer
Study Closed: January, 2011
A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015.
Publications based on the results of this research:
- The Lancet article, “Spray-applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: a phase 2, multicentre, double-blind, randomised, placebo-controlled trial”
Clinical Study Sponsor: Baxter 550801/ICRC Research (OHMC and EHMC)
Type of Study: Fibrin Sealant Vascular Hemostasis
Study Closed: December, 2010
To evaluate the efficacy of FS VH S/D 500 s-apr for hemostasis in subjects receiving peripheral vascular ePTFE conduits, as compared to a control arm treated by manual compression with surgical gauze pads.
Publications based on the results of this research:
- Journal of Vascular Surgery article, “A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts”
Clinical Study Sponsor: Profibrix (with OHMC)
Type of Study: Fibrin Sealant
Study Closed: December, 2010
To compare efficacy and safety of TachoSil versus Fibrin sealant for the secondary hemostatic treatment of needle hole bleeding in vascular surgery.
Clinical Study Sponsor: Boehringer Ingelheim RE-COVER (with OHMC)
Type of Study: DVT/PE
Study Closed: 4th quarter, 2010
Acute DVT/PR study.
Publications based on the results of this research:
- Annual Society of Hematology abstract and presentation, “A Randomized Trial of Dabigatran Versus Warfarin in the Treatment of Acute Venous Thromboembolism (RE-COVER II)”
Clinical Study Sponsor: BTG International VV014 LOW-DOSE Varisolve
Type of Study: Varicose Veins
Study Closed: April, 2010
To determine the effect and safety of Varisolve® 0.125% [0.2%].
Clinical Study Sponsor: BTG International VV013 PILOT STUDY
Type of Study: Varicose Veins
Study Closed: August, 2009
To evaluate the effectiveness of Varisolve in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.
Clinical Study Sponsor: BTG International VV012
Type of Study: MRI Study
Study Closed:
To determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart).
Publications based on the results of this research:
- Journal of Vascular Surgery article, “Clinical significance of cerebrovascular gas emboli during polidocanol endovenous ultra-low nitrogen microfoam ablation and correlation with magnetic resonance imaging in patients with right-to-left shunt”
Clinical Study Sponsor: BTG International SAVVy
Type of Study: Observational study
Study Closed: February. 2009
A multi-center observational study of appearance and symptom improvement following treatment of varicose veins.