Percutaneous Intervention of the Carotid Arteries.EPICNCT00460187
EPIC US Pivotal Study
A study testing Percutaneous intervention of the carotid artery in people with Percutaneous Intervention of the Carotid Arteries., run by Lumen Biomedical at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Intervention of the Carotid Arteries.
- What is being tested?
- Percutaneous intervention of the carotid artery
- Type of treatment
- Medical device
- How many people
- 237 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Jun 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.
- Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hoag Hospital
Newport Beach, California, 92663
Heart Hospital of South Dakota
Sioux Falls, South Dakota, 57108
About this study
Official title: Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.
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.
- Being tested
- Percutaneous intervention of the carotid artery
- Keywords
- carotid artery, distal protection device, carotid stenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous intervention of the carotid arteryDevice
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)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startMar 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Intervention of the Carotid Arteries.Studies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumen Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J. Michael Bacharach, MD, Principal investigator, Heart Hospital of South DakotaSubbarao Mylavarapu, MD, Principal investigator, Hoag Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460187
- Sponsor's protocol ID
- 90-1145
- Acronym
- EPIC
- Status last verified
- Oct 2008
- First submitted
- 11 Apr 2007
- 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 Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.
- ClinicalTrials.gov ID
- NCT00460187
- Acronym / sponsor ID
- EPIC / 90-1145
- Keywords
- carotid artery, distal protection device, carotid stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Lumen BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Study completion
- Jun 2008 (actual)
- First posted
- 13 Apr 2007 (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, 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.
Study design
- Primary purpose
- Treatment
- 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 (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Percutaneous intervention of the carotid artery | Device | – |
Primary outcome
The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.
1 secondary outcome
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.
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.
- Lumen Biomedical websiteLink provided by the sponsor.
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
Heart Hospital of South Dakota
Subbarao Mylavarapu, MD principal investigator
Hoag Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous intervention of the carotid artery in people with Percutaneous Intervention of the Carotid Arteries., run by Lumen Biomedical at 2 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 2 inclusion and 13 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 2 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; AzTrials last refreshed its copy on 29 Oct 2026.