Trial · NCT01343667
GORE Flow Reversal System and GORE Embolic Filter Extension Study
NCT01343667, Not applicable, Completed, W.L.Gore & Associates; results first posted 2016-02-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GORE Flow Reversal System and GORE Embolic Filter Extension Study. Trials, record NCT01343667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01343667
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GORE Flow Reversal System and GORE Embolic Filter Extension Study
- NCT number
- NCT01343667
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,397 participants, actual
- Lead sponsor
- W.L.Gore & Associates
- Conditions
Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Arterial Occlusive Diseases, Vascular Diseases, Cardiovascular Diseases, Pathological Conditions, Anatomical
- Interventions
- Gore Flow Reversal System, Gore Embolic Filter
- First posted
- 2011-04-28
- Last updated
- 2016-02-19
- Results first posted
- 2016-02-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Adverse Events (MAE) | Onset from start of index procedure to 30-day follow-up assessment | Major Adverse Events include death, stroke and myocardial infarction |
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 | Major Adverse Events (MAE) | Onset from start of index procedure to 30-day follow-up assessment | Enrolled subjects with successful procedure and sufficient follow-up | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Major Adverse Events (MAE) | GFRS EPD | 18 | participants | ||
| Major Adverse Events (MAE) | GEF EPD | 36 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GFRS EPD | 425 | |
| Overall Study | STARTED | GEF EPD | 972 | |
| Overall Study | COMPLETED | GFRS EPD | 413 | |
| Overall Study | COMPLETED | GEF EPD | 916 | |
| Overall Study | NOT COMPLETED | GFRS EPD | 12 | |
| Overall Study | NOT COMPLETED | GEF EPD | 56 |
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 |
|---|---|---|---|---|---|---|
| serious | All Cause Death | Cardiac disorders | GFRS EPD | 2 | 425 | 2 |
| serious | All Cause Death | Cardiac disorders | GEF EPD | 10 | 972 | 10 |
| serious | Myocardial Infarction | Cardiac disorders | GFRS EPD | 6 | 425 | 6 |
| serious | Myocardial Infarction | Cardiac disorders | GEF EPD | 3 | 972 | 3 |
| serious | Stroke | Nervous system disorders | GFRS EPD | 14 | 425 | 14 |
| serious | Stroke | Nervous system disorders | GEF EPD | 31 | 972 | 31 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GFRS EPD | ||
| Total, all-cause mortality | GEF EPD | ||
| Total, other adverse events | GFRS EPD | 0 | 425 |
| Total, other adverse events | GEF EPD | 0 | 972 |
| Total, serious adverse events | GFRS EPD | 18 | 425 |
| Total, serious adverse events | GEF EPD | 36 | 972 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GFRS EPD vs GEF EPD: Major Adverse Events (MAE) | Trial comparisons |
| GFRS EPD vs GEF EPD: serious adverse events | Trial comparisons |
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/NCT01343667
GET https://conductscience.org/api/trials/v1/NCT01343667/registered