Carotid Artery StenosisNCT00346515
EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting
A study testing FiberNet Emboli Protection System in people with Carotid Artery Stenosis, run by Lumen Biomedical at 4 sites in United States.
Trial summary
Multicenter, prospective, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention using the Guidant Acculink carotid stent in high surgical risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- FiberNet Emboli Protection System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2006to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One or more of the high surgical risk criteria.
- Candidate for percutaneous stenting with target lesion located within common or internal carotid artery.
- Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.
Who cannot join
- Allergy to Heparin.
- Myocardial infarction within the last 14 days.
- Angioplasty or PTCA/PTA procedure within the past 48 hours.
- Cardiac surgery within the past 60 days.
- Planned invasive surgical procedure within 30 days.
- Stroke within the past 14 days.
Show all 17Show fewer
- Transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
- Intracranial stenosis that exceeded the severity of an extracranial stenosis.
- Peripheral vascular disease of sufficient severity to prevent vascular access to the target lesion.
- 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 because of one or more of:
- Tortuous or calcified anatomy proximal or distal to the stenosis
- Presence of visual thrombus
- Pseudo occlusion ('string sign')
- Serial lesions that requires more then one stent to cover entire lesion.
- Procedural complication prior to introduction of the FiberNet device into the body.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Riverside Methodist Hospital
Columbus, Ohio, 43214
Hoag Hospital
Newport Beach, California, 92658
North Central Heart Institue
Sioux Falls, South Dakota, 57108
Washington Adventist Hospital
Takoma Park, Maryland, 20912
About this study
Official title: Evaluating the Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting: The EPIC US Feasibility Study
Multicenter, prospective, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention using the Guidant Acculink carotid stent in high surgical risk patients.
- Conditions
- Carotid Artery Stenosis
- Being tested
- FiberNet Emboli Protection System
- Keywords
- carotid artery, carotid stenosis, carotid stenting, embolic protection
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberNet Emboli Protection SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.
Secondary outcomes (1)
All death and all stroke rates; Non-stroke neurological event rates; Technical success rates; Procedural success rates; Access site complication rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startJun 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Lumen Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J. Michael Bacharach, MD, Principal investigator, North Central Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346515
- Sponsor's protocol ID
- 864
- Status last verified
- Oct 2008
- First submitted
- 29 Jun 2006
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting: The EPIC US Feasibility Study
- ClinicalTrials.gov ID
- NCT00346515
- Acronym / sponsor ID
- 864
- Conditions
- Carotid Artery Stenosis
- Keywords
- carotid artery, carotid stenosis, carotid stenting, embolic protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Lumen BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Jan 2008 (actual)
- First posted
- 30 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, prospective, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention using the Guidant Acculink carotid stent in high surgical risk patients.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- One or more of the high surgical risk criteria.
- Candidate for percutaneous stenting with target lesion located within common or internal carotid artery.
- Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.
Key exclusion criteria (17 listed)
- Allergy to Heparin.
- Myocardial infarction within the last 14 days.
- Angioplasty or PTCA/PTA procedure within the past 48 hours.
- Cardiac surgery within the past 60 days.
- Planned invasive surgical procedure within 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiberNet Emboli Protection System | Device | – |
Primary outcome
The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.
1 secondary outcome
All death and all stroke rates; Non-stroke neurological event rates; Technical success rates; Procedural success rates; Access site complication rates
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
Related trials for Carotid Artery Stenosis
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Michael Bacharach, MD principal investigator
North Central Heart Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FiberNet Emboli Protection System in people with Carotid Artery Stenosis, run by Lumen Biomedical at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2008.