Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities (017)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc. ( BTG Ltd. )
ClinicalTrials.gov Identifier:
NCT01197833
First received: September 8, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is 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.


Condition Intervention Phase
Great Saphenous Vein Incompetence
Visible Varicosities
Drug: polidocanol injectable microfoam 0.125%
Drug: polidocanol injectable microfoam 1.0%, endovenous ablation
Drug: vehicle (no polidocanol), endovenous ablation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Blinded Study of Endovenous Thermal Ablation With or Without Varisolve™ Polidocanol Endovenous Microfoam (PEM) Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Absolute change from baseline in appearance of visible varicose veins as assessed by Independent Photography Review (IPR)and patient self assessment [ Time Frame: 8 weeks post treatment ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: September 2010
Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endovenous ablation, polidocanol injectable microfoam 0.125%
Endovenous ablation, polidocanol injectable microfoam 0.125%
Drug: polidocanol injectable microfoam 0.125%
All components except API
Other Name: polidocanol endovenous microfoam
Experimental: Endovenous ablation, polidocanol injectable micrfoam, 1.0%
Endovenous ablation, polidocanol injectable microfoam, 1.0%
Drug: polidocanol injectable microfoam 1.0%, endovenous ablation
Active Comparator: endovenous ablation, vehicle
endovenous ablation, vehicle
Drug: vehicle (no polidocanol), endovenous ablation

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Incompetence of SFJ
  • Patients who are candidates for ETA [laser or radiofrequency ablation (RFA)]
  • Symptomatic varicose veins
  • Visible varicose veins
  • Ability to comprehend and sign an informed consent and complete study questionnaires in English

Exclusion Criteria:

  • Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders)
  • Patients who have active ulceration on the leg to be treated (Clinical Finding C6, as assessed by CEAP Classification of Venous Disorders)
  • Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure compression bandaging and stockings
  • Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
  • Deep venous reflux unless clinically insignificant in comparison to superficial reflux
  • Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
  • Reduced mobility
  • History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior DVT on duplex ultrasound
  • Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
  • Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
  • Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions
  • Current alcohol or drug abuse
  • Pregnant or lactating women
  • Women of childbearing potential not using effective contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197833

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85255
United States, Florida
Bradenton, Florida, United States, 34209
United States, Illinois
Oak Brook, Illinois, United States, 60523
United States, New York
North Tonawanda, New York, United States, 14120
Stony Brook, New York, United States, 11974
United States, North Carolina
Charlotte, North Carolina, United States, 28207
United States, Washington
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
BTG Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: BTG International Inc. ( BTG Ltd. )
ClinicalTrials.gov Identifier: NCT01197833     History of Changes
Other Study ID Numbers: VAP.VV017
Study First Received: September 8, 2010
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by BTG International Inc.:
varicose veins
Great saphenous vein
varicosities

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014