Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment
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|
Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment
Male or female participants from 20 years up to 60 years old.
- 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.
- 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.
|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.|
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