Varicose VeinsPhase 2MRINCT00442364
Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
A Phase 2 study testing Polidocanol (1%) Microfoam (Varisolve) and Endovenous Microfoam Occlusion in people with Varicose Veins, run by Boston Scientific Corporation at 7 sites in United States.
Trial summary
The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Polidocanol (1%) Microfoam (Varisolve) and Endovenous Microfoam Occlusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2007to Aug 2009
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females aged 18 to 60 with severe varicose veins, CEAP classes 3, 4 and 5 (CEAP is a classification and grading system for chronic venous disease)
- Saphenofemoral junction (SFJ) incompetence. Retrograde blood flow in the GSV, greater than or equal to 1.0 second demonstrated by duplex scanning.
- Normal MRI, as assessed on MRI examination performed within 5 days prior to procedure.
- Patient must be willing and able to participate in the study and provide written informed consent.
Who cannot join
- Presence of venous ulcers (i.e. CEAP classification C6) or local infection in the limb to be treated.
- Incompetence of the small saphenous vein (SSV) in the leg to be treated. Venographic or ultrasonographic evidence of current or previous deep vein thrombosis (DVT) (see Appendix IV).
- Deep venous occlusion and/or incompetence. Evidence of deep venous reflux is acceptable if it is confined to a limited segment caused by filling of the incompetent superficial system through a perforator or the SFJ.
- Patients with known atherosclerotic disease or presence of major risk factors, including LDL cholesterol greater than 130 mg/dl, blood pressure greater than 140 mmHg systolic or 90 mmHg diastolic, or diabetes requiring treatment with oral hypoglycemic drugs or insulin.
- Smokers.
- History suggestive of cerebral atherosclerosis, transient ischemic attack (TIA), stroke, presence of carotid bruit or history of abnormal carotid duplex examination.
Show all 29Show fewer
- Clinically significant dilated cardiomyopathy, evidence of regional wall motion abnormalities suggestive of prior myocardial infarction, rheumatic mitral valve disease, moderately severe or worsening cardiac valvular disease (> 2+ on a scale of 4), known or suspected congenital heart disease, evidence of right sided volume or pressure overload, history of atrial fibrillation. Patients with PFO, atrial septal defect, or other right-to-left shunt are not excluded unless associated with other abnormalities as above.
- Peripheral vascular disease.
- Spontaneous emboli seen on TCD prior to contrast injection.
- Body Mass Index >30.0.
- Recent or current upper respiratory tract illness or other cause of increased coughing.
- Arterial insufficiency in the leg to be treated (ankle: brachial pressure ratio less than 0.9).
- Reduced mobility - unable to maintain a brisk walk unaided for a minimum of 5 minutes per hour per day.
- Prolonged automobile or air travel (>4 hours) 1 month prior to treatment, or planned within 1 month of proposed treatment.
- Current or prior pulmonary embolism.
- Major surgery, prolonged hospitalization or pregnancy within 3 months of screening.
- Hormone replacement therapy or hormonal contraception (oral or dermal patch).
- Current or recent (<7 days before treatment) aldehyde dehydrogenase inhibitor therapy, e.g. disulfiram, or other drugs with similar reactions to alcohol (metronidazole, tinidazole).
- Current anticoagulation therapy.
- Inability to identify a unilateral or bilateral temporal bone window and middle cerebral artery signal by transcranial Doppler ultrasound.
- Inability to undergo magnetic resonance imaging of the brain
- Participation in a clinical study involving an unlicensed pharmaceutical product within the 3 months of screening.
- Previous enrollment in this study.
- Major co-existing disease (e.g. malignancy, pulmonary disease, renal or hepatic insufficiency).
- Known allergic response to polidocanol or severe and multiple allergic reactions.
- Women of childbearing potential not using effective contraception
- Pregnant or lactating women.
- Current alcohol or drug abuse.
- Clinically significant laboratory abnormalities in the opinion of the investigator.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Bellevue, Washington, 98004
Study site
Durham, North Carolina, 27710
Study site
Houston, Texas, 77030
Study site
Los Angeles, California, 90033
Study site
Philadelphia, Pennsylvania, 19107
Study site
Pittsburgh, Pennsylvania, 15232
Study site
Winston-Salem, North Carolina, 27157
About this study
Official title: An Open Label Multicenter Safety Study of the Varisolve® Procedure for the Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart).
Read the detailed description
Varicose veins are extremely common, affecting up to 25% of the western adult population. While in their early stages they are little more than a sometimes-painful aesthetic problem, progression is inevitable and some will progress to more severe and largely irreversible problems of chronic venous insufficiency (CVI) and, finally, venous leg ulcer. At present, no system has been proven to identify those that will progress and while varicose veins are not the only cause of CVI, in approximately 50% of patients with leg ulcers, superficial varicose veins are the only causal factor identified. The cost of management of simple varicose veins is relatively small in comparison with the long-term management of CVI and leg ulcers. Many patients progress to develop leg ulcers without having received primary treatment for their varicose veins.
The current management of major varicose veins includes maintenance by compression stockings, injection sclerotherapy with liquid sclerosants, and superficial vein surgery. The disadvantages to surgery include the use of general anesthesia, incisions resulting in possible scars, a painful recovery period with significant functional down time and historically high rates of recurrence. Sclerotherapy has been performed since 1851 with the advent of hypodermic needles. The two surfactant sclerosants most widely used are sodium tetradecyl sulphate (STS, STD®, Sotradecol or Fibro-vein) and polidocanol (Macrogol 400 Ph Eur, Aethoxyskerol®). Sotradecol is the only FDA-approved sclerosant. With the advent of duplex ultrasound scanning, the technique of echo-guided sclerotherapy has widened the possibilities for sclerotherapy of large veins but the liquid sclerosants available are rapidly deactivated and diluted by blood frequently resulting in unsatisfactory outcomes. Because the microfoam delivers sclerosant more efficiently to the venous endothelium, it is believed that lower concentrations of polidocanol (Varisolve)can be used when compared with liquid sclerosant. BTG International Ltd is developing sclerosant microfoam technology based on polidocanol (PD)(Varisolve) into a pharmaceutical product.
The presence of bubbles in the heart has been a concern as bubbles may pass from the right heart to the left through a patent foramen ovale (PFO) or other right-to-left shunt. Once in the systemic circulation, some bubbles inevitably pass into the cerebral circulation where their theoretical potential for causing damage due to occlusion of vessels is recognized yet ill defined.
Therefore this study is to determine whether patients with bubbles detected in the middle cerebral artery (MCA) during the Varisolve® procedure experience any sub-clinical, safety-related events such as abnormalities on brain MRI, neurological examination, cardiac markers or other symptoms or signs.
- Conditions
- Varicose Veins
- Being tested
- Polidocanol (1%) Microfoam (Varisolve), Endovenous Microfoam Occlusion
- Keywords
- PFO, Patent Foramen Ovale, Right-to-Left Shunt, Sclerotherapy
- Medical subject headings
- Varicose Veins, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polidocanol (1%) Microfoam (Varisolve)Drug
Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein.
Endovenous Microfoam OcclusionProcedure or surgery
Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Polidocanol (1%) Microfoam (Varisolve) Receives: Drug: Polidocanol (1%) Microfoam (Varisolve); Procedure: Endovenous Microfoam Occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects
Measured: 28 day followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2008
- Study completionAug 2009
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janet Rush, MD, Study director, BTG International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442364
- Sponsor's protocol ID
- VAP.VV012
- Acronym
- MRI
- Status last verified
- Apr 2021
- First submitted
- 27 Feb 2007
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
- An Open Label Multicenter Safety Study of the Varisolve® Procedure for the Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
- ClinicalTrials.gov ID
- NCT00442364
- Acronym / sponsor ID
- MRI / VAP.VV012
- Conditions
- Varicose Veins
- Keywords
- PFO, Patent Foramen Ovale, Right-to-Left Shunt, Sclerotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Posted 26 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart).
Detailed description
Varicose veins are extremely common, affecting up to 25% of the western adult population. While in their early stages they are little more than a sometimes-painful aesthetic problem, progression is inevitable and some will progress to more severe and largely irreversible problems of chronic venous insufficiency (CVI) and, finally, venous leg ulcer. At present, no system has been proven to identify those that will progress and while varicose veins are not the only cause of CVI, in approximately 50% of patients with leg ulcers, superficial varicose veins are the only causal factor identified. The cost of management of simple varicose veins is relatively small in comparison with the long-term management of CVI and leg ulcers. Many patients progress to develop leg ulcers without having received primary treatment for their varicose veins.
The current management of major varicose veins includes maintenance by compression stockings, injection sclerotherapy with liquid sclerosants, and superficial vein surgery. The disadvantages to surgery include the use of general anesthesia, incisions resulting in possible scars, a painful recovery period with significant functional down time and historically high rates of recurrence. Sclerotherapy has been performed since 1851 with the advent of hypodermic needles. The two surfactant sclerosants most widely used are sodium tetradecyl sulphate (STS, STD®, Sotradecol or Fibro-vein) and polidocanol (Macrogol 400 Ph Eur, Aethoxyskerol®). Sotradecol is the only FDA-approved sclerosant. With the advent of duplex ultrasound scanning, the technique of echo-guided sclerotherapy has widened the possibilities for sclerotherapy of large veins but the liquid sclerosants available are rapidly deactivated and diluted by blood frequently resulting in unsatisfactory outcomes. Because the microfoam delivers sclerosant more efficiently to the venous endothelium, it is believed that lower concentrations of polidocanol (Varisolve)can be used when compared with liquid sclerosant. BTG International Ltd is developing sclerosant microfoam technology based on polidocanol (PD)(Varisolve) into a pharmaceutical product.
The presence of bubbles in the heart has been a concern as bubbles may pass from the right heart to the left through a patent foramen ovale (PFO) or other right-to-left shunt. Once in the systemic circulation, some bubbles inevitably pass into the cerebral circulation where their theoretical potential for causing damage due to occlusion of vessels is recognized yet ill defined.
Therefore this study is to determine whether patients with bubbles detected in the middle cerebral artery (MCA) during the Varisolve® procedure experience any sub-clinical, safety-related events such as abnormalities on brain MRI, neurological examination, cardiac markers or other symptoms or signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Polidocanol (1%) Microfoam (Varisolve), Procedure: Endovenous Microfoam OcclusionPolidocanol (1%) Microfoam (Varisolve) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females aged 18 to 60 with severe varicose veins, CEAP classes 3, 4 and 5 (CEAP is a classification and grading system for chronic venous disease)
- Saphenofemoral junction (SFJ) incompetence. Retrograde blood flow in the GSV, greater than or equal to 1.0 second demonstrated by duplex scanning.
- Normal MRI, as assessed on MRI examination performed within 5 days prior to procedure.
- Patient must be willing and able to participate in the study and provide written informed consent.
Key exclusion criteria (29 listed)
- Presence of venous ulcers (i.e. CEAP classification C6) or local infection in the limb to be treated.
- Incompetence of the small saphenous vein (SSV) in the leg to be treated. Venographic or ultrasonographic evidence of current or previous deep vein thrombosis (DVT) (see Appendix IV).
- Deep venous occlusion and/or incompetence. Evidence of deep venous reflux is acceptable if it is confined to a limited segment caused by filling of the incompetent superficial system through a perforator or the SFJ.
- Patients with known atherosclerotic disease or presence of major risk factors, including LDL cholesterol greater than 130 mg/dl, blood pressure greater than 140 mmHg systolic or 90 mmHg diastolic, or diabetes requiring treatment with oral hypoglycemic drugs or insulin.
- Smokers.
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 (1%) Microfoam (Varisolve)Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein. | Drug | 1 |
| Endovenous Microfoam OcclusionVarisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries. | Procedure or surgery | 1 |
Primary outcome
Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects
Time frame: 28 day followup
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.
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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.
Janet Rush, MD study director
BTG International Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polidocanol (1%) Microfoam (Varisolve) and Endovenous Microfoam Occlusion in people with Varicose Veins, 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 4 inclusion and 29 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Feb 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?
Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects (time frame: 28 day followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.