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Prospective Randomized Endovascular Therapy in Multiple Sclerosis (PREMiSe)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Venous Angioplasty
Sham Angioplasty
Sponsored by
University at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65 years

    • EDSS 0-6.5
    • Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
    • Be on treatment with currently FDA approved disease-modifying treatments
    • Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
    • Demonstration of venous occlusive disease on cervical MRV
    • Normal renal function: creatinine clearance level of >60:

Constant= 1.23 for men; 1.04 for women

Exclusion Criteria:

  • • Relapse, disease progression and steroid treatment in the 30 days preceding study entry

    • Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.)
    • Severe peripheral chronic venous insufficiency
    • Abnormal renal function
    • Contrast allergy (anaphylaxis)
    • Not accepting to undergo the endovascular treatment
    • Peripheral Vascular Disease

Sites / Locations

  • Gates Circle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Venous Angioplasty

Angio with no plasty

Arm Description

20 patients will have venous angio plasty

Patients will be brought to the angio suite and given and angio but no plasty although patient will not be aware of which treatment they are having.

Outcomes

Primary Outcome Measures

SAE
Severe Adverse Events measured at 24 hours Immediate and 1 month Short term post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty

Secondary Outcome Measures

Full Information

First Posted
April 17, 2013
Last Updated
May 17, 2022
Sponsor
University at Buffalo
Collaborators
Volcano Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05380362
Brief Title
Prospective Randomized Endovascular Therapy in Multiple Sclerosis
Acronym
PREMiSe
Official Title
Prospective Randomized Endovascular Therapy in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
Volcano Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses in MS patients with CCSVI as documented by sonographic (extracranial echocolor-Doppler (ECD) and transcranial color Doppler (TCD) To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS). To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters. To evaluate change in patients self-reported QOL following the therapeutic angioplasty To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Venous Angioplasty
Arm Type
Experimental
Arm Description
20 patients will have venous angio plasty
Arm Title
Angio with no plasty
Arm Type
Sham Comparator
Arm Description
Patients will be brought to the angio suite and given and angio but no plasty although patient will not be aware of which treatment they are having.
Intervention Type
Other
Intervention Name(s)
Venous Angioplasty
Intervention Description
venous angiogram to look for lesions or flaps and then plastying vessels open.
Intervention Type
Other
Intervention Name(s)
Sham Angioplasty
Intervention Description
Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.
Primary Outcome Measure Information:
Title
SAE
Description
Severe Adverse Events measured at 24 hours Immediate and 1 month Short term post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 years EDSS 0-6.5 Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005) Be on treatment with currently FDA approved disease-modifying treatments Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section) Demonstration of venous occlusive disease on cervical MRV Normal renal function: creatinine clearance level of >60: Constant= 1.23 for men; 1.04 for women Exclusion Criteria: • Relapse, disease progression and steroid treatment in the 30 days preceding study entry Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.) Severe peripheral chronic venous insufficiency Abnormal renal function Contrast allergy (anaphylaxis) Not accepting to undergo the endovascular treatment Peripheral Vascular Disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan H Siddiqui, M.D., Ph. D.
Organizational Affiliation
University at Buffalo Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gates Circle Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Prospective Randomized Endovascular Therapy in Multiple Sclerosis

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