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

August 17, 2009 updated by: Lumen Biomedical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

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

  • United States
    • Florida
      • Ocala, Florida, United States, 34474
        • Munroe Regional Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • St. Vincent Hospital
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Christ Hospital
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • LeHigh Valley Hospital

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 transluminal coronary angioplasty (PTCA), stenting and emergent coronary artery bypass graft (CABG).

  • Myocardial ischemia as evidenced by one or more of the following:

    • Diagnosis of stable or unstable angina pectoris
    • ECG changes consistent with ischemia
    • Positive functional study
    • Recent myocardial infarction
  • Lesion(s) is located within SVG and is ≥ 50% and < 100% stenosed.

Exclusion Criteria:

Clinical Criteria:

  • 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.
  • 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).

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
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints.
Time Frame: index hospitalization
index hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumen Biomedical

Investigators

  • Robert Feldman, MD, Munroe Regional Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 28, 2007

First Submitted That Met QC Criteria

March 28, 2007

First Posted (Estimate)

March 29, 2007

Study Record Updates

Last Update Posted (Estimate)

August 18, 2009

Last Update Submitted That Met QC Criteria

August 17, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90-1004

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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