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Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment | Clinical Trials | Clareo Health

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

NCT01593891•Synergy Health Concepts, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 60 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Synergy Health Concepts Inc.

Newport Beach, California, United States

Key Dates

Start Date

August 1, 2011

Completion Date

September 1, 2012

Last Updated

May 8, 2012

Enrollment

ACTUAL participants

Conditions

To Determine the Safety and Validity of Venous Angioplasty andValvuloplasty in the Treatment of CCSVI. In Addition, it WillAllow Researchers to Sub-classify Valve Morphology in Relationto Treatment Success. This Will be Evidenced by Venous PatencyForty-eight Hours by Doppler Ultrasound as Well as ClinicalSymptom Improvement.