Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

NCT01231373 | Completed Phase 3 Results DMC

• 1 other identifier: VAP.VV016
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 12

Brief Summary

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 three different concentrations of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Conditions

Varicose Veins

Keywords

varicose veins

Outcome Measures

Primary Outcomes (1)

• Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)

  The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINES QOL/Sym items that have been determined in earlier studies to be most important to patients. The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25). At Visit 2/baseline, Week 8, scores were calculated.

  8 weeks

Secondary Outcomes (2)

• Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)

  8 weeks

• Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance

  8 weeks

Study Arms (4)

polidocanol injectable foam, 0.125%

EXPERIMENTAL

Drug: polidocanol injectable foam, 0.125%

polidocanol injectable foam, 0.5%

EXPERIMENTAL

Drug: polidocanol injectable foam, 0.5%

polidocanol injectable foam, 1.0%

EXPERIMENTAL

Drug: polidocanol injectable foam, 1.0%

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

polidocanol injectable foam, 0.125% DRUG

active placebo for blinding

polidocanol injectable foam, 0.125%

polidocanol injectable foam, 0.5% DRUG

0.5% polidocanol foam injection

polidocanol injectable foam, 0.5%

polidocanol injectable foam, 1.0% DRUG

1.0% polidocanol foam injection

polidocanol injectable foam, 1.0%

Vehicle DRUG

injection of vehicle comparator

Vehicle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
• Ability to comprehend and sign an informed consent document and complete study questionnaires in English
• Ability to record symptoms in accordance with the protocol
• Symptomatic varicose veins
• Visible varicose veins

You may not qualify if:

• Patients who only have telangiectatic or reticular veins (Clinical Finding C1, 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 vein reflux unless clinically insignificant in comparison to superficial reflux
• Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
• Reduced mobility
• 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
• History of DVT, pulmonary embolism, or stroke

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (12)

Unknown Facility

Dothan, Alabama, 36303, United States

Location

Unknown Facility

San Diego, California, 92120, United States

Location

Unknown Facility

San Diego, California, 92121, United States

Location

Unknown Facility

Lafayette, Indiana, 47905, United States

Location

Unknown Facility

Frederick, Maryland, 21701, United States

Location

Unknown Facility

Hunt Valley, Maryland, 21030, United States

Location

Unknown Facility

Los Alamos, New Mexico, 87544, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73104, United States

Location

Unknown Facility

Monroeville, Pennsylvania, 15143, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15232, United States

Location

Unknown Facility

Greenville, South Carolina, 29615, United States

Location

Unknown Facility

Bellevue, Washington, 98004, United States

Location

Related Publications (1)

• Todd KL 3rd, Wright DI; VANISH-2 Investigator Group. Durability of treatment effect with polidocanol endovenous microfoam on varicose vein symptoms and appearance (VANISH-2). J Vasc Surg Venous Lymphat Disord. 2015 Jul;3(3):258-264.e1. doi: 10.1016/j.jvsv.2015.03.003. Epub 2015 May 6.

  PMID: 26992303 DERIVED

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: David Wright MBBS
• Organization: BTG International Inc.

david.wright@btgplc.com

610-278-1660

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: November 1, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: August 1, 2014
• Last Updated: April 21, 2021
• Results First Posted: April 2, 2014

Record last verified: 2021-04

Locations

US (12)