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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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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 Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No