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Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment (Resrch_Reg_2)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Synergy Health Concepts, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01593891
First Posted: May 8, 2012
Last Update Posted: May 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Synergy Health Concepts, Inc.
  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

Further study details as provided by Synergy Health Concepts, Inc.:

Enrollment: 45
Study Start Date: August 2011
Estimated Study Completion Date: September 2012
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593891


Locations
United States, California
Synergy Health Concepts Inc.
Newport Beach, California, United States, 92660
Sponsors and Collaborators
Synergy Health Concepts, Inc.
Investigators
Principal Investigator: Michael Arata, MD Study Principal Investigator
  More Information

Additional Information:
Responsible Party: Synergy Health Concepts, Inc.
ClinicalTrials.gov Identifier: NCT01593891     History of Changes
Other Study ID Numbers: RESEARCH_REGISTRY_2
First Submitted: May 6, 2012
First Posted: May 8, 2012
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Synergy Health Concepts, Inc.:
IVUS, CCSVI


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