Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment

• Conditions: To Determine the Safety and Validity of Venous Angioplasty and; Valvuloplasty in the Treatment of CCSVI. In Addition, it Will; Allow Researchers to Sub-classify Valve Morphology in Relation; to Treatment Success. This Will be Evidenced by Venous Patency; Forty-eight Hours by Doppler Ultrasound as Well as Clinical; Symptom Improvement.

• Registration Number: NCT01593891
• Lead Sponsor: Synergy Health Concepts, Inc.

Brief Summary

Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment

Detailed Description

To determine the safety and validity of venous angioplasty and valvuloplasty in the treatment of CCSVI. In addition, it will allow researchers to sub-classify valve morphology in relation to treatment success. This will be evidenced by venous patency forty-eight hours by Doppler ultrasound as well as clinical symptom improvement.

Study Timeline

• Study Start: 2011-08
• Status Verified: 2012-05
• Study First Submitted: 2012-05-06
• Study First Submitted QC: 2012-05-06
• Last Update Submitted: 2012-05-06
• Study First Posted: 2012-05-08
• Last Update Posted: 2012-05-08
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent
• Males or Females between the ages of 20 and 60 years of age.
• Voluntary agreement to participate in the study: Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment.

Exclusion Criteria

• Any implantable/metallic objects that prevents subject from having a magnetic resonance imaging (MRI/MRV) study.
• History of uncontrolled hypertension
• Previous CCSVI treatment
• Presence of hypercoagulable state
• Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women, fetuses, and cognitively impaired individuals who are unable to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Synergy Health Concepts Inc.; 🇺🇸 Newport Beach, California, United States