Great Saphenous Vein IncompetencePhase 3017NCT01197833
Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
A Phase 3 study testing endovenous ablation+polidocanol injectable microfoam 0.125%, Endovenous ablation+polidocanol injectable microfoam 1.0% and Endovenous ablation+polidocanol injectable foam 2.0% in people with Great Saphenous Vein Incompetence and Visible Varicosities, run by Boston Scientific Corporation at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Great Saphenous Vein Incompetence, Visible Varicosities
- What is being tested?
- endovenous ablation+polidocanol injectable microfoam 0.125%, Endovenous ablation+polidocanol injectable microfoam 1.0% and Endovenous ablation+polidocanol injectable foam 2.0%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2010to Dec 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
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Bradenton, Florida, 34209
Study site
Charlotte, North Carolina, 28207
Study site
Kirkland, Washington, 98034
Study site
North Tonawanda, New York, 14120
Study site
Oak Brook, Illinois, 60523
Study site
Scottsdale, Arizona, 85255
Study site
Stony Brook, New York, 11974
About this study
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
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.
- Being tested
- endovenous ablation+polidocanol injectable microfoam 0.125%, Endovenous ablation+polidocanol injectable microfoam 1.0%, Endovenous ablation+polidocanol injectable foam 2.0%
- Keywords
- varicose veins, Great saphenous vein, varicosities
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovenous ablation+polidocanol injectable microfoam 0.125%Drug
Also called endovenous ablation followed by polidocanol endovenous microfoam 0.125% injection to target vein
All components except API
Endovenous ablation+polidocanol injectable microfoam 1.0%Drug
Also called Endovenous ablation followed by injection of polidocanol injectable foam 1.0% to target vein
endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%
Endovenous ablation+polidocanol injectable foam 2.0%Drug
Also called Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%
Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%
| Study group | Role | What they receive |
|---|---|---|
| Endovenous ablation+polidocanol injectable microfoam 0.125% | Experimental | Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein Receives: Drug: endovenous ablation+polidocanol injectable microfoam 0.125% |
| Endovenous ablation+polidocanol injectable micrfoam, 1.0% | Experimental | Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein Receives: Drug: Endovenous ablation+polidocanol injectable microfoam 1.0% |
| endovenous ablation+vehicle (placebo) | Active comparator | endovenous ablation followed by injection of vehicle (placebo) to target vein Receives: Drug: Endovenous ablation+polidocanol injectable foam 2.0% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)
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 screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins.
Measured: IPR-V3 measured at baseline and then at 8 weeks
Absolute Change From Baseline in PA-V3 Score
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 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: PA-V3 measured at baseline and then at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionDec 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 Great Saphenous Vein IncompetenceStudies 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197833
- Sponsor's protocol ID
- VAP.VV017
- Acronym
- 017
- Status last verified
- Apr 2021
- First submitted
- 8 Sep 2010
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vasquez M, Gasparis AP; Varithena(R) 017 Investigator Group. A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. Phlebology. 2017 May;32(4):272-281. doi: 10.1177/0268355516637300. Epub 2016 Mar 7.
PubMed 26957489
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 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
- ClinicalTrials.gov ID
- NCT01197833
- Acronym / sponsor ID
- 017 / VAP.VV017
- Keywords
- varicose veins, Great saphenous vein, varicosities
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endovenous ablation+polidocanol injectable microfoam 0.125% | Experimental | Drug: endovenous ablation+polidocanol injectable microfoam 0.125%Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein |
| Endovenous ablation+polidocanol injectable micrfoam, 1.0% | Experimental | Drug: Endovenous ablation+polidocanol injectable microfoam 1.0%Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein |
| endovenous ablation+vehicle (placebo) | Active comparator | Drug: Endovenous ablation+polidocanol injectable foam 2.0%endovenous ablation followed by injection of vehicle (placebo) to target vein |
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
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| endovenous ablation+polidocanol injectable microfoam 0.125%Also: endovenous ablation followed by polidocanol endovenous microfoam 0.125% injection to target veinAll components except API | Drug | Endovenous ablation+polidocanol injectable microfoam 0.125% |
| Endovenous ablation+polidocanol injectable microfoam 1.0%Also: Endovenous ablation followed by injection of polidocanol injectable foam 1.0% to target veinendovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0% | Drug | Endovenous ablation+polidocanol injectable micrfoam, 1.0% |
| Endovenous ablation+polidocanol injectable foam 2.0%Also: Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0% | Drug | endovenous ablation+vehicle (placebo) |
Primary outcome
Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)
Time frame: IPR-V3 measured at baseline and then at 8 weeks
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 screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins.
Absolute Change From Baseline in PA-V3 Score
Time frame: PA-V3 measured at baseline and then at 8 weeks
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 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)
Results and safety
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 26957489Vasquez M, Gasparis AP; Varithena(R) 017 Investigator Group. A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. Phlebology. 2017 May;32(4):272-281. doi: 10.1177/0268355516637300. Epub 2016 Mar 7.
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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.
7 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 endovenous ablation+polidocanol injectable microfoam 0.125%, Endovenous ablation+polidocanol injectable microfoam 1.0% and Endovenous ablation+polidocanol injectable foam 2.0% in people with Great Saphenous Vein Incompetence and Visible Varicosities, run by Boston Scientific Corporation at 7 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 14 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 7 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. 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 15 Sep 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?
Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) (time frame: IPR-V3 measured at baseline and then at 8 weeks). The study lists 2 primary outcomes in all. 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 NCT01197833, 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.