Overview

This trial is active, not recruiting.

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.
Sponsor Synergy Health Concepts, Inc.
Start date August 2011
End date September 2012
Trial size 45 participants
Trial identifier NCT01593891, RESEARCH_REGISTRY_2

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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.

Additional Information

Official title Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment
Principal investigator Michael Arata, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Synergy Health Concepts, Inc..