EPIC US Pivotal Study | NCT00460187

Studies
EPIC US Pivotal Study

NCT00460187

Sponsor

Lumen Biomedical

Status

Completed

Last Update Posted

Oct 21, 2008Estimated

Enrollment

237Actual

Phase

Not Applicable

Conditions

Percutaneous Intervention of the Carotid Arteries.

Interventions

Percutaneous intervention of the carotid artery

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Jun 2008Actual

First Submitted Date

Apr 11, 2007

First Submission Date that Met QC Criteria

Apr 11, 2007

First Posted Date

Apr 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2008

Last Update Posted Date

Oct 21, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

237Actual

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous intervention of the carotid artery	Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
J. Michael Bacharach, MD	Heart Hospital of South Dakota	Principal Investigator
Subbarao Mylavarapu, MD	Hoag Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hoag Hospital		Newport Beach	California	92663	United States
Heart Hospital of South Dakota

Type	Date	Date Unknown
Release	Aug 17, 2009
Reset	Sep 24, 2009