Trial Outcomes & Findings for Prospective Randomized Endovascular Therapy in Multiple Sclerosis (NCT NCT05380362)

Results Overview

Percent (%) of patients with Severe Adverse Events (SAE) measured at 1 month (Short term) post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty. The 95% confidence interval of the SAE rates for immediate and short terms will be obtained by the exact method, respectively. The immediate and short term SAE rates will be analyzed, respectively, using the Fisher's exact test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

1 month post-procedure

Results posted on

2025-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Venous Angioplasty Venous Angioplasty: venous angiogram to look for lesions or flaps and then plastying vessels open.	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. Sham Angioplasty: Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.
Overall Study STARTED	10	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Venous Angioplasty n=9 Participants Venous Angioplasty: venous angiogram to look for lesions or flaps and then plastying vessels open.	Angio With no Plasty n=10 Participants 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. Sham Angioplasty: Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.	Total n=19 Participants Total of all reporting groups
Age, Continuous	43.3 years STANDARD_DEVIATION 8.2 • n=9 Participants	44.8 years STANDARD_DEVIATION 10.5 • n=10 Participants	44.1 years STANDARD_DEVIATION 9.4 • n=19 Participants
Sex: Female, Male Female	5 Participants n=9 Participants	8 Participants n=10 Participants	13 Participants n=19 Participants
Sex: Female, Male Male	4 Participants n=9 Participants	2 Participants n=10 Participants	6 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 Participants n=9 Participants	10 Participants n=10 Participants	19 Participants n=19 Participants

PRIMARY outcome

Timeframe: 1 month post-procedure

Percent (%) of patients with Severe Adverse Events (SAE) measured at 1 month (Short term) post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty. The 95% confidence interval of the SAE rates for immediate and short terms will be obtained by the exact method, respectively. The immediate and short term SAE rates will be analyzed, respectively, using the Fisher's exact test.

Outcome measures

Outcome measures
Measure	Venous Angioplasty n=9 Participants Venous Angioplasty: venous angiogram to look for lesions or flaps and then plastying vessels open.	Angio With no Plasty n=10 Participants 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. Sham Angioplasty: Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.
Percentage of Patients With Immediate and Short-term SAE	0 Participants	0 Participants

Adverse Events

Venous Angioplasty

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Angio With no Plasty

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Venous Angioplasty n=9 participants at risk Venous Angioplasty: venous angiogram to look for lesions or flaps and then plastying vessels open.	Angio With no Plasty n=10 participants at risk 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. Sham Angioplasty: Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.
Immune system disorders Immune thrombocytopenic purpura	0.00% 0/9	10.0% 1/10
Renal and urinary disorders Bladder infection	0.00% 0/9	10.0% 1/10
Nervous system disorders Shingles	0.00% 0/9	10.0% 1/10
Cardiac disorders Cardiac event	11.1% 1/9	0.00% 0/10
General disorders Swelling & Soreness	11.1% 1/9	0.00% 0/10
Renal and urinary disorders Transobturator sling	11.1% 1/9	0.00% 0/10

Additional Information

Dr. Ellen Carl

UBNS

Phone: 716-218-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place