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

Primary Purpose

Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FiberNet EPS used during SVG intervention.
Sponsored by
Lumen Biomedical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Saphenous Vein Graft Disease focused on measuring SVG, Saphenous Vein Graft, Embolic Protection, Distal Protection, EPD, FiberNet, Saphenous Vein Graft intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Munroe Regional Medical Center
  • St. Vincent Hospital
  • William Beaumont Hospital
  • Christ Hospital
  • Riverside Methodist Hospital
  • Lehigh Valley Hospital

Outcomes

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.

Secondary Outcome Measures

The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints.

Full Information

First Posted
March 28, 2007
Last Updated
August 17, 2009
Sponsor
Lumen Biomedical
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1. Study Identification

Unique Protocol Identification Number
NCT00453518
Brief Title
The RETRIEVE Study: Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts
Acronym
RETRIEVE
Official Title
Evaluating the Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts: The RETRIEVE Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lumen Biomedical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism
Keywords
SVG, Saphenous Vein Graft, Embolic Protection, Distal Protection, EPD, FiberNet, Saphenous Vein Graft intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
FiberNet EPS used during SVG intervention.
Other Intervention Name(s)
stenting
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints.
Time Frame
index hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Feldman, MD
Organizational Affiliation
Munroe Regional Medical Center
Facility Information:
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
St. Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.lumenbio.com
Description
Lumen Biomedical website

Learn more about this trial

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

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