Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01864941

Enrollment

104

Registered

2013-05-30

Start date

2013-05-31

Completion date

2017-08-01

Last updated

2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, MS, CCSVI, Zamboni, catheter venography, balloon angioplasty

Brief summary

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.

Detailed 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

Interventions

PROCEDURECatheter venography with balloon venoplasty

All eligible patients will undergo catheter venography with balloon venoplasty and/or sham at baseline and at week 48 (i.e. Cross over design) followed by clinical and radiologic observation for a minimum of 48 weeks after each procedure.

DEVICECatheter venography with balloon venoplasty and balloon

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events	48 weeks	To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis (MS) patients with CCSVI as measured by adverse events occurring within 48 weeks of the procedure.

Secondary

Measure	Time frame	Description
Clinical Outcome	48 weeks	To evaluate the efficacy of balloon venoplasty compared to sham as reflected by patient reported quality of life, pain and fatigue scales 48 weeks after the procedure.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026