Trial Outcomes & Findings for Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt (NCT NCT00442364)

Last Updated: 2021-04-21

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

28 day followup

Results posted on

2021-04-21

Participant milestones
Measure	Polidocanol 1% Injectable Microfoam polidocanol injectable microfoam 1%
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt

Baseline characteristics by cohort
Measure	Safety Evaluable n=60 Participants patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
Age, Continuous	43.6 years STANDARD_DEVIATION 9.17 • n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	48 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	59 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

Timeframe: 28 day followup

Outcome measures
Measure	Safety Evaluable Population n=60 Participants polidocanol injectable foam 1% with circulating MCA bubbles present at MRI
Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects	0 participants

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events
Measure	Safety Evaluable n=60 participants at risk patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
Vascular disorders Deep vein thrombosis	6.7% 4/60 • Number of events 4 • 12 months after treatment

Other adverse events
Measure	Safety Evaluable n=60 participants at risk patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
General disorders Pain in extrermity	40.0% 24/60 • Number of events 24 • 12 months after treatment
Vascular disorders hematoma evacuation	13.3% 8/60 • Number of events 8 • 12 months after treatment
Vascular disorders deep vein thrombosis	5.0% 3/60 • Number of events 3 • 12 months after treatment
Musculoskeletal and connective tissue disorders limb discomfort	5.0% 3/60 • Number of events 3 • 12 months after treatment
Vascular disorders ecchymosis	5.0% 3/60 • Number of events 3 • 12 months after treatment

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