Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Scientific Corporation; BTG International Inc.
• Treatments: Polidocanol

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.