Varicose VeinsPhase 3VANISH-1NCT01072877

Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

A Phase 3 study testing Polidocanol injectable foam (PEM) in people with Varicose Veins, run by Boston Scientific Corporation at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Varicose Veins
What is being tested?: Polidocanol injectable foam (PEM)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 279 participants
Where: 20 sitesUnited States
Study dates: Dec 2010to Nov 2012
Phase: Phase 3
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP (clinical, etiologic, anatomic, and pathophysiologic) Classification of Venous Disorders).
Leg obesity impairing the ability to access the vein to be treated and/or to apply postprocedure 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

Show all 13Show fewer

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

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Ann Arbor, Michigan, 48109
Study site
Aventura, Florida, 33180
Study site
Bend, Oregon, 97701
Study site
Bradenton, Florida, 34209
Study site
Charlotte, North Carolina, 28207
Study site
Clarksville, Tennessee, 37040
Study site
Durham, North Carolina, 27705
Study site
Hartsdale, New York, 10530
Study site
Kalamazoo, Michigan, 49009
Study site
Kirkland, Washington, 98034
Study site
Laguna Hills, California, 92653
Study site
New York, New York, 10016
Study site
North Tonawanda, New York, 14120
Study site
Oakbrook Terrace, Illinois, 60181
Study site
San Diego, California
Study site
Spokane, Washington, 99204
Study site
Stony Brook, New York, 10530
Study site
Toledo, Ohio, 43606
Study site
Washington D.C., District of Columbia, 20007
Study site
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Polidocanol Injectable Foam 0.5%, 1.0%, or 2.0% Compared to Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

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 injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Conditions: Varicose Veins
Being tested: Polidocanol injectable foam (PEM), Placebo Vehicle
Keywords: Varicose Veins
Medical subject headings: Varicose Veins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Polidocanol injectable foam (PEM)Drug
Injection of Polidocanol injectable foam
Placebo VehicleDrug
Placebo vehicle

Study groups in NCT01072877
Study group	Role	What they receive
Polidocanol injectable foam 0.125%	Experimental	Polidocanol injectable foam 0.125% Receives: Drug: Polidocanol injectable foam (PEM)
Polidocanol injectable foam 0.5%	Experimental	Polidocanol injectable foam 0.5% Receives: Drug: Polidocanol injectable foam (PEM)
Polidocanol injectable foam 1.0%	Experimental	Polidocanol injectable foam 1.0% Receives: Drug: Polidocanol injectable foam (PEM)
Polidocanol injectable foam 2.0%	Experimental	Polidocanol injectable foam 2.0% Receives: Drug: Polidocanol injectable foam (PEM)
Vehicle	Placebo comparator	Injection of vehicle comparator Receives: Drug: Placebo Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

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 of 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 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching).
The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity).
At Visit 2/baseline, Week 8, scores were calculated
Measured: Week 8

Secondary outcomes (2)

Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)
The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4).
Measured: 8 weeks
Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance
The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (where 0=none to 4=very severe visible varicose veins).
Measured: 8 weeks post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Nov 2012

First posted22 Feb 2010 (estimated)
Study startDec 2010
Primary completionDec 2011
Study completionNov 2012

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Varicose VeinsStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 279 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01072877
Sponsor's protocol ID: VAP.VV015
Acronym: VANISH-1
Status last verified: Apr 2021
First submitted: 19 Feb 2010
Last updated: 21 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

King JT, O'Byrne M, Vasquez M, Wright D; VANISH-1 Investigator Group. Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance. Eur J Vasc Endovasc Surg. 2015 Dec;50(6):784-93. doi: 10.1016/j.ejvs.2015.06.111. Epub 2015 Sep 16.
PubMed 26384639

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Polidocanol Injectable Foam 0.5%, 1.0%, or 2.0% Compared to Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
ClinicalTrials.gov ID: NCT01072877
Acronym / sponsor ID: VANISH-1 / VAP.VV015
Conditions: Varicose Veins
Keywords: Varicose Veins
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 279 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Dec 2011 (actual)
Study completion: Nov 2012 (actual)
First posted: 22 Feb 2010 (estimated)
Results: Posted 16 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Polidocanol injectable foam 0.125%	Experimental	Drug: Polidocanol injectable foam (PEM)Polidocanol injectable foam 0.125%
Polidocanol injectable foam 0.5%	Experimental	Drug: Polidocanol injectable foam (PEM)Polidocanol injectable foam 0.5%
Polidocanol injectable foam 1.0%	Experimental	Drug: Polidocanol injectable foam (PEM)Polidocanol injectable foam 1.0%
Polidocanol injectable foam 2.0%	Experimental	Drug: Polidocanol injectable foam (PEM)Polidocanol injectable foam 2.0%
Vehicle	Placebo comparator	Drug: Placebo VehicleInjection of vehicle comparator

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (13 listed)

Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP (clinical, etiologic, anatomic, and pathophysiologic) Classification of Venous Disorders).
Leg obesity impairing the ability to access the vein to be treated and/or to apply postprocedure 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

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
Polidocanol injectable foam (PEM)Injection of Polidocanol injectable foam	Drug	Polidocanol injectable foam 0.125%, Polidocanol injectable foam 0.5%, Polidocanol injectable foam 1.0%, Polidocanol injectable foam 2.0%
Placebo VehiclePlacebo vehicle	Drug	Vehicle

Primary outcome

Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)
Time frame: Week 8
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 of 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 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching). The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity). At Visit 2/baseline, Week 8, scores were calculated

2 secondary outcomes

Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)
Time frame: 8 weeks
Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance
Time frame: 8 weeks post treatment

Results and safety

Results posted to the registry on 16 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vehicle	56	55
Polidocanol Endovenous Microfoam 0.125%	57	56
Polidocanol Endovenous Microfoam 0.5%	51	51
Polidocanol Endovenous Microfoam 1.0%	52	50
Polidocanol Endovenous Microfoam 2.0%	63	63

Primary outcome: Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)

Time frame: Week 8. Mean (Standard Error). Unit: units on a scale

Measure	Vehicle n = 55	Polidocanol Injectable Foam 0.125% n = 56	Polidocanol Injectable Foam 0.5% n = 51	Polidocanol Injectable Foam 1.0% n = 50	Polidocanol Injectable Foam 2.0% n = 63
Value	2.13 (0.452)	4.63 (0.447)	5.68 (0.483)	4.87 (0.477)	5.78 (0.425)

Vehicle vs Polidocanol Injectable Foam 0.125%: Mean Difference (Final Values): -2.49 (95% CI -3.72 to -1.27), p =0.0001, ANCOVA
Vehicle vs Polidocanol Injectable Foam 0.5%: Mean Difference (Final Values): -3.54 (95% CI -4.80 to -2.29), p <0.0001, ANCOVA
Vehicle vs Polidocanol Injectable Foam 1.0%: Mean Difference (Final Values): -2.73 (95% CI -3.98 to -1.48), p <0.0001, ANCOVA

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vehicle	0 of 56 (0%)	20 of 56 (35.7%)	Not reported
Polidocanol Injectable Foam 0.125%	0 of 57 (0%)	38 of 57 (66.7%)	Not reported
Polidcanol Injectable Foam 0.5%	0 of 51 (0%)	46 of 51 (90.2%)	Not reported
Polidocanol Injectable Foam 1.0%	0 of 52 (0%)	41 of 52 (78.8%)	Not reported
Polidocanol Endovenous Microfoam 2.0%	0 of 63 (0%)	50 of 63 (79.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26384639King JT, O'Byrne M, Vasquez M, Wright D; VANISH-1 Investigator Group. Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance. Eur J Vasc Endovasc Surg. 2015 Dec;50(6):784-93. doi: 10.1016/j.ejvs.2015.06.111. Epub 2015 Sep 16.

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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.

The record lists no contact. Use the official record to reach the sponsor.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Polidocanol injectable foam (PEM) in people with Varicose Veins, run by Boston Scientific Corporation at 20 sites 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 13 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: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2014). 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?

Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01072877, which also lists 1 linked publication.

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 21 Apr 2021.