Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
Condition: Varicose Veins
MeSH terms: Varicose Veins
Intervention: Polidocanol (1%) Microfoam (Varisolve); Endovenous Microfoam Occlusion
Intervention description: Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein.; Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries.
Intervention MeSH terms: Polidocanol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: PFO; Patent Foramen Ovale; Right-to-Left Shunt; Sclerotherapy

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.

          -  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.