NCT00460187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

First QC Date

April 11, 2007

Last Update Submit

October 20, 2008

Conditions

Percutaneous Intervention of the Carotid Arteries.

Keywords

carotid artery, distal protection device, carotid stenting

Outcome Measures

Primary Outcomes (1)

  • The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.

Secondary Outcomes (1)

  • 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.

Interventions

Percutaneous intervention of the carotid arteryDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hoag Hospital

Newport Beach, California, 92663, United States

Location

Heart Hospital of South Dakota

Sioux Falls, South Dakota, 57108, United States

Location

Related Links

Study Officials

  • J. Michael Bacharach, MD

    Heart Hospital of South Dakota

    PRINCIPAL INVESTIGATOR

  • Subbarao Mylavarapu, MD

    Hoag Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 13, 2007

Study Start

March 1, 2007

Study Completion

June 1, 2008

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

US(2)