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)

Microvention-Terumo, Inc.37 sites in 1 country295 target enrollmentApril 21, 2016

ConditionsCarotid Artery Stenosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Carotid Artery Stenosis
Sponsor: Microvention-Terumo, Inc.
Enrollment: 295
Locations: 37
Primary Endpoint: All stroke, death, and MI
Status: Active, Not Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 21, 2016

End Date

May 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Microvention-Terumo, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is between \>21 and ≤80 years of age.
•Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone.
•Patient or authorized legal representative is willing to provide written informed consent prior to enrollment in study.
•Patient should have been diagnosed with carotid artery stenosis and be considered a high operative risk for carotid endarterectomy.
•Patient is either:
•Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as amaurosis fugax ipsilateral to the carotid lesion; TIA or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; or
•Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology.
•Patient has a target lesion located at the carotid bifurcation and/or proximal ICA.
•Patient has a single de novo or restenotic (post CEA) target lesion or severe tandem lesions close enough that can be covered by a single Roadsaver™ stent.
•Patients having a vessel with reference diameters between 3.0 mm and 9.0 mm at the target lesion.

Exclusion Criteria

•Patient has life expectancy of less than one year.
•Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke in the last 30 days.
•Patient has anticipated or potential sources of emboli (e.g. known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or deep vein thrombosis (DVT) treated within 6 months) that are not adequately treated with antithrombotics for at least two weeks with documented coagulation parameters in the target therapeutic range.
•Patient has atrial fibrillation.
•Patient has had an acute myocardial infarction within 60 days prior to index procedure.
•Patient has had or plans to have any major surgical procedure (i.e. intraabdominal or intrathoracic surgery or any surgery/interventional procedure involving cardiac or vascular system) within 30 days of the index procedure.
•Patient has a history of major ipsilateral stroke.
•Patient has \>60% carotid stenosis contralateral to the target lesion requiring treatment prior to completion of thes study-required 12 month follow-up.
•Patient has a modified Rankin Scale of \>2 or has another neurological deficit not due to stroke that may confound the neurological patient assessments.
•Patient has chronic renal insufficiency (serum creatinine ≥2.5 mg/dL) or has a history of severe hepatic impairment, malignant hypertension, and/or is morbidly obese.