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

Synergy Health Concepts

Status: Unknown

Conditions: to Treatment Success. This Will be Evidenced by Venous Patency; Allow Researchers to Sub-classify Valve Morphology in Relation; To Determine the Safety and Validity of Venous Angioplasty and; Valvuloplasty in the Treatment of CCSVI. In Addition, it Will; Forty-eight Hours by Doppler Ultrasound as Well as Clinical; Symptom Improvement.

Study type: Observational

Funder types: Industry

Identifiers

NCT01593891

RESEARCH_REGISTRY_2

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.