Trial Outcomes & Findings for Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE (NCT NCT01450072)
NCT ID: NCT01450072
Last Updated: 2025-06-18
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.
COMPLETED
NA
20 participants
24 hours-1 month
2025-06-18
Participant Flow
Participant milestones
| Measure |
Venography & Sham Angioplasty
Venography and sham angioplasty
Control arm: Venography and sham angioplasty
|
Therapeutic Balloon Angioplasty
therapeutic balloon angioplasty
Selective Venography followed by therapeutic balloon angioplasty: Venography followed by therapeutic balloon angioplasty
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Arm
n=10 Participants
Venography and sham angioplasty
Control arm: Venography and sham angioplasty
|
Active Arm
n=9 Participants
therapeutic balloon angioplasty
Selective Venography followed by therapeutic balloon angioplasty: Venography followed by therapeutic balloon angioplasty
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
19 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=19 Participants
|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 10.5 • n=10 Participants
|
43.3 years
STANDARD_DEVIATION 8.2 • n=9 Participants
|
44.1 years
STANDARD_DEVIATION 9.4 • n=19 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=10 Participants
|
5 Participants
n=9 Participants
|
13 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants
|
4 Participants
n=9 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
|
10 participants
n=10 Participants
|
9 participants
n=9 Participants
|
19 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: 24 hours-1 monthPercent (%) 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
| Measure |
Control Arm
n=10 Participants
Venography and sham angioplasty
Control arm: Venography and sham angioplasty
|
Active Arm
n=9 Participants
therapeutic balloon angioplasty
Selective Venography followed by therapeutic balloon angioplasty: Venography followed by therapeutic balloon angioplasty
|
|---|---|---|
|
Percentage of Patients With Immediate and Short-term SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 months, and 1 year post-angioplastyRestoration of venous outflow (more than 75% of normal outflow) as measured by the combined ECD/TCD and MRV at 1 year following the angioplasty as compared to baseline as well as compared to a parallel control group of MS patients that will undergo only selective venography without balloon angioplasty (sham-angioplasty). These comparisons will be accomplished by the hierarchical linear model which takes into account the correlation within subjects. Based on the residuals, we will check the normality assumptions by the normal quantile plot and skewness.
Outcome measures
| Measure |
Control Arm
n=10 Participants
Venography and sham angioplasty
Control arm: Venography and sham angioplasty
|
Active Arm
n=9 Participants
therapeutic balloon angioplasty
Selective Venography followed by therapeutic balloon angioplasty: Venography followed by therapeutic balloon angioplasty
|
|---|---|---|
|
Number of Participants With More Than 75% of Normal Outflow at 1 Year Post-angioplasty
|
0 Participants
|
0 Participants
|
Adverse Events
Control Arm
Active Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Arm
n=10 participants at risk
Venography and sham angioplasty
Control arm: Venography and sham angioplasty
|
Active Arm
n=9 participants at risk
therapeutic balloon angioplasty
Selective Venography followed by therapeutic balloon angioplasty: Venography followed by therapeutic balloon angioplasty
|
|---|---|---|
|
Immune system disorders
Immune thrombocytopenic purpura
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Renal and urinary disorders
Bladder infection
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Shingles
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Cardiac disorders
Cardiac event
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Swelling & Soreness
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Transobturator sling
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place