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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Synergy Health Concepts, Inc.
ClinicalTrials.gov Identifier:
NCT01593891
First received: May 6, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted

May 6, 2012
May 6, 2012
August 2011
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No Changes Posted
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Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment
Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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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.

  • 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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
September 2012
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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.
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01593891
RESEARCH_REGISTRY_2
Yes
Synergy Health Concepts, Inc.
Synergy Health Concepts, Inc.
Not Provided
Principal Investigator: Michael Arata, MD Study Principal Investigator
Synergy Health Concepts, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP