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The RETRIEVE Study: Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts

This study is currently recruiting participants.
Verified by Lumen Biomedical, April 2008

Sponsored by: Lumen Biomedical
Information provided by: Lumen Biomedical
ClinicalTrials.gov Identifier: NCT00453518
  Purpose

This is a multicenter, prospective study designed to demonstrate the performance and safety of the FiberNet Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) intervention.


Condition Intervention
Saphenous Vein Graft Disease
Myocardial Ischemia
Embolism
Device: FiberNet EPS used during SVG intervention.

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study
Official Title:   Evaluating the Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts: The RETRIEVE Study

Further study details as provided by Lumen Biomedical:

Primary Outcome Measures:
  • The primary objective of the study is to evaluate the safety and performance of the FiberNet Embolic Protection System. The primary endpoint is major adverse cardiac events (MACE) rate at 30 days. [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints.

Estimated Enrollment:   30
Study Start Date:   March 2007
Estimated Study Completion Date:   August 2008
Estimated Primary Completion Date:   June 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Device: FiberNet EPS used during SVG intervention.
    The FiberNet EPS is indicated for use as a guide wire and embolic protection system to capture and remove embolic material produced while performing percutaneous transluminal interventional procedures in saphenous vein grafts.
Detailed Description:

The study will involve up to 30 patients to be enrolled using the FiberNet device during clinically indicated percutaneous intervention of SVG and followed through 30 days post procedure. Patients will be enrolled at up to 10 Investigative Sites. The study is a prospective multi-center registry with sequential enrollment of qualified patients who consent to participate and meet all entrance criteria.

The Lumen Biomedical, Inc. FiberNet® Embolic Protection System is indicated for use as a guide wire and embolic protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in saphenous vein grafts with reference vessel diameters of 1.75 mm to 7.0 mm.

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

Criteria

Inclusion Criteria:

  • Candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting and emergent coronary artery bypass graft (CABG).
  • Total CK and CK-MB verified to be within hospital normal limits at the time of enrollment.
  • Myocardial ischemia as evidenced by one or more of the following:

    • Diagnosis at time of enrollment of stable or unstable angina pectoris
    • Reversible 12-lead electrocardiogram (ECG) changes consistent with ischemia
    • Positive functional study (e.g. stress test)
    • Recent myocardial infarction ( > 24 hours prior to enrollment with total CK and CK-MB verified to be within hospital normal limits at the time of enrollment).
  • Lesion(s) is located within SVG and is ≥ 50% and < 100% stenosed. The patient may have one or two SVG grafts to be treated and each SVG may have more than one lesion.
  • Vessel has thrombolysis in myocardial infarction (TIMI) Grade 1 or higher flow before or after the passage of a non-study guidewire.
  • Reference vessel diameter where the FiberNet filter device is to be placed is ≥ 1.75 mm and ≤ 7.0 mm in diameter by careful visual estimation.
  • Lesion(s) can be treated/pre-treated with PTCA balloons and/or stent only (cutting balloon is allowed).
  • 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:

Clinical Criteria:

  • Known allergy to heparin and bivalirudin (Angiomax).
  • Myocardial infarction with documented total CK-MB > 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
  • Undergone cardiac surgery within the past 60 days.
  • A planned invasive surgical procedure within 30 days.
  • The lesion(s) is in an SVG that is less than 2 months post-implant.
  • Left ventricular ejection fraction < 20%.
  • A stroke or transient ischemic neurological attack (TIA) within the past 2 months.

Angiographic Criteria:

  • The lesion(s) is in an arterial conduit.
  • Anatomical exclusions that preclude placement of the FiberNet device per the Instructions for Use.
  • Lesion is within 10 mm of the proximal anastomosis.
  • More than two native lesions [in addition to the SVG lesion(s)] that need to be treated at the index procedure.
  • More than two SVGs that need to be treated at the index procedure.
  • Chronic total occlusion of a target lesion.
  • The SVG lesion(s) requires treatment with a large device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, rheolytic thrombectomy or brachytherapy).
  • Procedural complication prior to introduction of the FiberNet device into the body.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453518

Contacts
Contact: Jill M Moland, BS, CCRP     763-746-9565     moland@lumenbio.com    
Contact: Rebecca Wetterling, BS, CCRP     763-746-9552     wetterling@lumenbio.com    

Locations
United States, Florida
Munroe Regional Medical Center     Recruiting
      Ocala, Florida, United States, 34474
      Principal Investigator: Robert Feldman, MD            
United States, Indiana
St. Vincent Hospital     Recruiting
      Indianapolis, Indiana, United States, 46290
      Principal Investigator: James Hermiller, MD            
United States, Michigan
William Beaumont Hospital     Recruiting
      Royal Oak, Michigan, United States, 48073
      Principal Investigator: Simon Dixon, MD            
United States, Ohio
Christ Hospital     Recruiting
      Cincinnati, Ohio, United States, 45219
      Principal Investigator: Dean Kereiakes, MD            
Riverside Methodist Hospital     Recruiting
      Columbus, Ohio, United States, 43214
      Principal Investigator: John Tugaoen, MD            
United States, Pennsylvania
Lehigh Valley Hospital     Terminated
      Allentown, Pennsylvania, United States, 18105

Sponsors and Collaborators
Lumen Biomedical

Investigators
Investigator:     Robert Feldman, MD     Munroe Regional Medical Center    
  More Information


Lumen Biomedical website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Lumen Biomedical, Inc. ( Jill Moland, Sr. CRA )
Study ID Numbers:   90-1004
First Received:   March 28, 2007
Last Updated:   April 21, 2008
ClinicalTrials.gov Identifier:   NCT00453518
Health Authority:   United States: Food and Drug Administration

Keywords provided by Lumen Biomedical:
SVG  
Saphenous Vein Graft  
Embolic Protection  
Distal Protection  
EPD
FiberNet
Saphenous Vein Graft intervention

Study placed in the following topic categories:
Embolism and Thrombosis
Heart Diseases
Embolism
Myocardial Ischemia
Vascular Diseases
Ischemia
Thrombosis

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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