Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment (Resrch_Reg_2)
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ClinicalTrials.gov Identifier: NCT01593891
Verified May 2012 by Synergy Health Concepts, Inc.. Recruitment status was: Active, not recruiting
Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment
Condition or disease
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.
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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Ages Eligible for Study:
20 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Many questions remain about how and when CCSVI might play a role in nervous system damage and whether venous angioplasty is helpful in treating the symptoms of CCSVI. Utilizing intravascular ultrasound (IVUS,) this pilot study will provide data that will allow researchers to evaluate venous morphology pre- and post- percutaneous angioplasty and sub-classify valve morphology as related to treatment success by distinguishing vessels which are more responsive to treatment. In addition, this study will validate the safety of valvuloplasty in various neurodegenerative disorders that involve venous obstruction.
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.