Status:
COMPLETED
Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Varicose Veins
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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).
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00442364
Start Date
March 1 2007
End Date
August 1 2009
Last Update
April 21 2021
Active Locations (7)
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1
Los Angeles, California, United States, 90033
2
Durham, North Carolina, United States, 27710
3
Winston-Salem, North Carolina, United States, 27157
4
Philadelphia, Pennsylvania, United States, 19107