Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

University of British Columbia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Sclerosis

Treatments: Procedure: Catheter venography with balloon venoplasty; Device: Catheter venography with balloon venoplasty and balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT01864941

H12-01153

Details and patient eligibility

About

To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by adverse events occurring within 48 weeks of the procedure.

Full description

Overview of study objectives are:

• To determine the safety and tolerability of venoplasty of CCSVI in Multiple Sclerosis (MS).
• To determine the short term and long term impact on validated patient measures and by physician and radiologic reported MS outcomes.
• To determine the short term and long term recurrence rate of CCSVI for veins that have been treated with venoplasty

Enrollment: 104 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive MS according to the McDonald criteria 2010
• Age 18 to 65 years inclusive
• Neurostatus (EDSS) score at screening from 0 to 6.5
• Fulfill ultrasound criteria for CCSVI

Exclusion criteria

• Previous venoplasty and/or stenting of extra cranial venous system

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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104 participants in 2 patient groups

Catheter Venography & Balloon Venoplasty

Active Comparator group

Description:

Patients will undergo catheter venography with balloon venoplasty procedure.

Treatment:

Device: Catheter venography with balloon venoplasty and balloon

Procedure: Catheter venography with balloon venoplasty

Catheter Venography Only

Sham Comparator group

Description:

Patients will undergo catheter venography only.

Treatment:

Procedure: Catheter venography with balloon venoplasty