Carotid Artery StenosisNCT00309803
EPIC European Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting
A study testing FiberNet Embolic Protection Device in people with Carotid Artery Stenosis, run by Lumen Biomedical at 3 sites in Germany.
Trial summary
Multicenter, prospective, 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. The primary endpoint is the rate of all stoke and death within 30 days of the procedure. 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 Embolic Protection Device
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesGermany
- Study dates
- Mar 2006to not given
- 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
- 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.
- Targeted vessel diameter for FiberNet placement between 1.75 mm and 7.0 mm.
- The investigator determines that all branch vessels distal to the target lesion and proximal to the proposed site of device deployment will be adequately protected.
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.
- Has a planned invasive surgical procedure within 30 days.
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- Suffered a stroke within the past 14 days.
- Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
- Total occlusion of the target vessel.
- Lesions within 2 cm 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.
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Evaluating the Use of the FiberNet® Embolic Protection Device in Carotid Artery Stenting: The EPIC European Study
Multicenter, prospective, 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. The primary endpoint is the rate of all stoke and death within 30 days of the procedure.
Read the detailed description
The purpose of this feasibility study is to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention. The feasibility study will involve a maximum of 50 subjects to be enrolled using the FiberNet® during clinically indicated percutaneous intervention of the carotid artery and followed through 30 days post procedure. Subject will be enrolled in up to 5 European Investigational Sites. The study is a prospective multi-center registry with sequential enrollment of qualified subjects who consent to participate and meet all entrance criteria.
- Conditions
- Carotid Artery Stenosis
- Being tested
- FiberNet Embolic Protection Device
- Keywords
- Carotid artery, distal protection device
- 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 Embolic Protection DeviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the rate of all death and stroke within 30 days of the procedure.
Secondary outcomes (2)
All death, stroke, and myocardial infarction 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 posted3 Apr 2006 (estimated)
- Study startMar 2006
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumen Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joachim Schofer, Prof. med., Principal investigator, Andreas-Gruntzig-Haus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309803
- Sponsor's protocol ID
- 872
- Status last verified
- Oct 2008
- First submitted
- 30 Mar 2006
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
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 Device in Carotid Artery Stenting: The EPIC European Study
- ClinicalTrials.gov ID
- NCT00309803
- Acronym / sponsor ID
- 872
- Conditions
- Carotid Artery Stenosis
- Keywords
- Carotid artery, distal protection device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lumen BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- First posted
- 3 Apr 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, 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. The primary endpoint is the rate of all stoke and death within 30 days of the procedure.
Detailed description
The purpose of this feasibility study is to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention. The feasibility study will involve a maximum of 50 subjects to be enrolled using the FiberNet® during clinically indicated percutaneous intervention of the carotid artery and followed through 30 days post procedure. Subject will be enrolled in up to 5 European Investigational Sites. The study is a prospective multi-center registry with sequential enrollment of qualified subjects who consent to participate and meet all entrance criteria.
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 (4 listed)
- 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.
- Targeted vessel diameter for FiberNet placement between 1.75 mm and 7.0 mm.
- The investigator determines that all branch vessels distal to the target lesion and proximal to the proposed site of device deployment will be adequately protected.
Key exclusion criteria (12 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 |
|---|---|---|
| FiberNet Embolic Protection Device | Device | – |
Primary outcome
The primary endpoint is the rate of all death and stroke within 30 days of the procedure.
2 secondary outcomes
All death, stroke, and myocardial infarction 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.
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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.
Joachim Schofer, Prof. med. principal investigator
Andreas-Gruntzig-Haus
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FiberNet Embolic Protection Device in people with Carotid Artery Stenosis, run by Lumen Biomedical at 3 sites in Germany.
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 4 inclusion and 12 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 3 sites in Germany. 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 primary endpoint is the rate of all death and stroke 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.