Trials / Completed
CompletedNCT01343667
GORE Flow Reversal System and GORE Embolic Filter Extension Study
The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,397 (actual)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
Detailed description
Physicians will have the opportunity to select which embolic protection device, the GORE Flow Reversal System or the GORE Embolic Filter, to use during the carotid artery stenting procedure. This study is not designed to compare study endpoints between the two treatment arms.
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Gore Flow Reversal System | Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting |
| DEVICE | Gore Embolic Filter | Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2013-11-01
- Completion
- 2014-01-01
- First posted
- 2011-04-28
- Last updated
- 2016-02-19
- Results posted
- 2016-02-19
Locations
39 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01343667. Inclusion in this directory is not an endorsement.