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

NCT00442364 | Completed Phase 2 Results DMC

• 1 other identifier: VAP.VV012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

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).

Conditions

Varicose Veins

Keywords

PFO; Patent Foramen Ovale; Right-to-Left Shunt; Sclerotherapy

Outcome Measures

Primary Outcomes (1)

• Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects

  28 day followup

Study Arms (1)

1

EXPERIMENTAL

Polidocanol (1%) Microfoam (Varisolve)

Drug: Polidocanol (1%) Microfoam (Varisolve); Procedure: Endovenous Microfoam Occlusion

Interventions

Polidocanol (1%) Microfoam (Varisolve) DRUG

Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein.

1

Endovenous Microfoam Occlusion PROCEDURE

Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries.

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (7)

Unknown Facility

Los Angeles, California, 90033, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19107, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15232, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Varicose Veins; Foramen Ovale, Patent

Interventions

Polidocanol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: David DI Wright MB BS
• Organization: BTG International Inc

david.wright@btgplc.com

610-278-1660

Study Officials

• Janet Rush, MD

  BTG International Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: March 1, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2009
• Last Updated: April 21, 2021
• Results First Posted: February 26, 2014

Record last verified: 2021-04

Locations

US (7)