PREMiSe: Prospective Randomized Endovascular Therapy in Multiple Sclerosis

• Sponsor: University at Buffalo (Other)
• Overall Status: Completed
• CT.gov ID: NCT05380362
• Collaborator: Volcano Corporation (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

1. 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)

2. To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS).

3. To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters.

4. To evaluate change in patients self-reported QOL following the therapeutic angioplasty

5. To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Venous Angioplasty; Other: Sham Angioplasty	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Endovascular Therapy in Multiple Sclerosis
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Venous Angioplasty 20 patients will have venous angio plasty	Other: Venous Angioplasty; venous angiogram to look for lesions or flaps and then plastying vessels open.
Sham Comparator: Angio with no 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.	Other: Sham Angioplasty; Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.

Outcome Measures

Primary Outcome Measures

1. SAE [24 hours]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18-65 years

• EDSS 0-6.5

• Diagnosis of relapsing MS according to the McDonald criteria (Polman et al.,

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gates Circle Hospital	Buffalo	New York	United States	14209

Sponsors and Collaborators

• University at Buffalo
• Volcano Corporation

Investigators

• Principal Investigator: Adnan H Siddiqui, M.D., Ph. D., University at Buffalo Neurosurgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adnan H. Siddiqui, MD, PhD, Associate Professor of Neurosurgery and Radiology, University at Buffalo
• ClinicalTrials.gov Identifier: NCT05380362
• Other Study ID Numbers: PREM 01; NSG1730210B
• First Posted: May 18, 2022
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Keywords provided by Adnan H. Siddiqui, MD, PhD, Associate Professor of Neurosurgery and Radiology, University at Buffalo: Multiple Sclerosis
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

No Results Posted as of May 18, 2022