Trial · NCT00442364
Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
NCT00442364, Phase 2, Completed, Boston Scientific Corporation; results first posted 2014-02-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt. Trials, record NCT00442364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00442364
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
- NCT number
- NCT00442364
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Varicose Veins
- Interventions
- Polidocanol (1%) Microfoam (Varisolve), Endovenous Microfoam Occlusion
- First posted
- 2007-03-01
- Last updated
- 2021-04-21
- Results first posted
- 2014-02-26
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects | 28 day followup |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects | 28 day followup | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects | Safety Evaluable Population | 0 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Polidocanol 1% Injectable Microfoam | 60 | |
| Overall Study | COMPLETED | Polidocanol 1% Injectable Microfoam | 60 | |
| Overall Study | NOT COMPLETED | Polidocanol 1% Injectable Microfoam | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain in extrermity | General disorders | Safety Evaluable | 24 | 60 | 24 |
| other | hematoma evacuation | Vascular disorders | Safety Evaluable | 8 | 60 | 8 |
| other | deep vein thrombosis | Vascular disorders | Safety Evaluable | 3 | 60 | 3 |
| other | limb discomfort | Musculoskeletal and connective tissue disorders | Safety Evaluable | 3 | 60 | 3 |
| other | ecchymosis | Vascular disorders | Safety Evaluable | 3 | 60 | 3 |
| serious | Deep vein thrombosis | Vascular disorders | Safety Evaluable | 4 | 60 | 4 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Evaluable | ||
| Total, other adverse events | Safety Evaluable | 30 | 60 |
| Total, serious adverse events | Safety Evaluable | 4 | 60 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00442364
GET https://conductscience.org/api/trials/v1/NCT00442364/registered