Trials / Unknown
UnknownNCT02657707
Evaluation of the Roadsaver Stent Used in Conjunction With the Nanoparasol Embolic Protection System for Carotid Artery Stenosis
Pivotal Study of the MicroVention, Inc. Carotid Artery Stent System Used in Conjunction With the Nanoparasol® Embolic Protection System for the Treatment of Carotid Artery Stenosis in Patients at Elevated Risk for Adverse Events From Carotid Endarterectomy.(CONFIDENCE Trial)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 295 (estimated)
- Sponsor
- Microvention-Terumo, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multicenter, single-arm, open label clinical study to evaluate the safety and effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy.
Detailed description
Up to 295 patients will be enrolled for this study. All potential patients being considered for the study should have been diagnosed with significant carotid artery stenosis and be considered a high perioperative risk for carotid endarterectomy. Patients will be evaluated through screening, pre-procedure, index procedure, post-procedure. Follow-up visits will be completed at 30 days, 6 months, and 12, 24, and 36 months post-procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Roadsaver™ Carotid Artery Stent Device | The Roadsaver™ carotid artery stent system is indicated for use in patients with significant atherosclerotic disease of the carotid arteries. |
| DEVICE | Nanoparasol® Embolic Protection System | The Nanoparasol® embolic protection system is indicated for use with a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. |
Timeline
- Start date
- 2016-04-21
- Primary completion
- 2022-04-08
- Completion
- 2024-05-01
- First posted
- 2016-01-18
- Last updated
- 2023-02-28
Locations
37 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02657707. Inclusion in this directory is not an endorsement.