Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment (Resrch_Reg_2)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment
| Condition |
|---|
|
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 Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment |
| Enrollment: | 45 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | September 2012 |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations| United States, California | |
| Synergy Health Concepts Inc. | |
| Newport Beach, California, United States, 92660 | |
| Principal Investigator: | Michael Arata, MD | Study Principal Investigator |
More Information
Additional Information:
No publications provided
| Responsible Party: | Synergy Health Concepts, Inc. |
| ClinicalTrials.gov Identifier: | NCT01593891 History of Changes |
| Other Study ID Numbers: | RESEARCH_REGISTRY_2 |
| Study First Received: | May 6, 2012 |
| Last Updated: | May 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Synergy Health Concepts, Inc.:
|
IVUS, CCSVI |
ClinicalTrials.gov processed this record on May 22, 2013