Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment (Resrch_Reg_2)
| Tracking Information | |||||
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| First Received Date ICMJE | May 6, 2012 | ||||
| Last Updated Date | May 6, 2012 | ||||
| Start Date ICMJE | August 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment | ||||
| Official Title ICMJE | Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment | ||||
| Brief Summary | Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 45 | ||||
| Estimated Completion Date | September 2012 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01593891 | ||||
| Other Study ID Numbers ICMJE | RESEARCH_REGISTRY_2 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Synergy Health Concepts, Inc. | ||||
| Study Sponsor ICMJE | Synergy Health Concepts, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Synergy Health Concepts, Inc. | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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