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
  Purpose

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.


Condition Intervention
Carotid Artery Stenosis
Device: FiberNet Embolic Protection Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Use of the FiberNet® Embolic Protection Device in Carotid Artery Stenting: The EPIC European Study

Resource links provided by NLM:


Further study details as provided by Lumen Biomedical:

Primary Outcome Measures:
  • The primary endpoint is the rate of all death and stroke within 30 days of the procedure.

Secondary Outcome Measures:
  • All death, stroke, and myocardial infarction rates; Non-stroke neurological event rates
  • Technical success rates; Procedural success rates; Access site complication rates

Estimated Enrollment: 50
Study Start Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309803

Locations
Germany
Dortmund, Germany
Frankfurt, Germany
Hamburg, Germany
Sponsors and Collaborators
Lumen Biomedical
Investigators
Principal Investigator: Joachim Schofer, Prof. med. Andreas-Gruntzig-Haus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00309803     History of Changes
Other Study ID Numbers: 872
Study First Received: March 30, 2006
Last Updated: October 20, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Lumen Biomedical:
Carotid artery
distal protection device

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014