EPIC US Pivotal Study

Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00460187

Acronym

EPIC

Enrollment

237

Registered

2007-04-13

Start date

2007-03-31

Completion date

2008-06-30

Last updated

2008-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Intervention of the Carotid Arteries.

Keywords

carotid artery, distal protection device, carotid stenting

Brief summary

Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients.

Interventions

DEVICEPercutaneous intervention of the carotid artery

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* One or more of the high surgical risk criteria. * Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.

Exclusion criteria

* Prior stenting of ipsilateral carotid. * Planned treatment of contralateral carotid within 30 days. * Experienced a myocardial infarction within the last 14 days. * Undergone an angioplasty or PTCA/PTA procedure within the past 48 hours. * Undergone cardiac surgery within the past 60 days. * Suffered a stroke within the past 14 days. * Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours. * Abnormal baseline blood counts; platelets \<50,000 or \>700,000/mm3 or WBC count \< 3 x103/uL. * Intracranial stenosis that exceeded the severity of an extracranial stenosis. * Total occlusion of the target vessel. * Lesion within 2cm of the ostium of the common carotid artery. * A stenosis that is known to be unsuitable for stenting * Serial lesions that requires more than one stent to cover entire lesion.

Design outcomes

Primary

Measure	Time frame
The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.	—

Secondary

Measure	Time frame
Secondary Endpoints are: all death and all stroke rates, non-stroke neurological event rates, technical success rates, procedural success rates, and access site complication rates.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026