- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00309803
EPIC European Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting
October 20, 2008 updated by: Lumen Biomedical
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dortmund, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion 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.
- 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.
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.
- Has a planned invasive surgical procedure within 30 days.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary endpoint is the rate of all death and stroke within 30 days of the procedure.
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Secondary Outcome Measures
Outcome Measure |
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All death, stroke, and myocardial infarction rates; Non-stroke neurological event rates
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Technical success rates; Procedural success rates; Access site complication rates
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joachim Schofer, Prof. med., Andreas-Gruntzig-Haus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Registration Dates
First Submitted
March 30, 2006
First Submitted That Met QC Criteria
March 30, 2006
First Posted (Estimate)
April 3, 2006
Study Record Updates
Last Update Posted (Estimate)
October 21, 2008
Last Update Submitted That Met QC Criteria
October 20, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 872
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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