EPIC European Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting

This study has been completed.
Sponsor:
Information provided by:
Lumen Biomedical
ClinicalTrials.gov Identifier:
NCT00309803
First received: March 30, 2006
Last updated: October 20, 2008
Last verified: October 2008

March 30, 2006
October 20, 2008
March 2006
Not Provided
The primary endpoint is the rate of all death and stroke within 30 days of the procedure.
Same as current
Complete list of historical versions of study NCT00309803 on ClinicalTrials.gov Archive Site
  • All death, stroke, and myocardial infarction rates; Non-stroke neurological event rates
  • Technical success rates; Procedural success rates; Access site complication rates
Same as current
Not Provided
Not Provided
 
EPIC European Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carotid Artery Stenosis
Device: FiberNet Embolic Protection Device
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00309803
872
No
Not Provided
Lumen Biomedical
Not Provided
Principal Investigator: Joachim Schofer, Prof. med. Andreas-Gruntzig-Haus
Lumen Biomedical
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP