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

Sponsor:	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.

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluating the Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts: The RETRIEVE Study

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints. [ Time Frame: index hospitalization ] [ Designated as safety issue: Yes ]

Enrollment:	29
Study Start Date:	March 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Other Name: stenting

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).
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).

Contacts and Locations

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

Locations

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

Sponsors and Collaborators

Lumen Biomedical

Investigators

Investigator:

Robert Feldman, MD

Munroe Regional Medical Center

More Information

Additional Information:

Lumen Biomedical website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jill Moland, Sr. CRA, Lumen Biomedical, Inc.
ClinicalTrials.gov Identifier:	NCT00453518 History of Changes
Other Study ID Numbers:	90-1004
Study First Received:	March 28, 2007
Last Updated:	August 17, 2009
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

Additional relevant MeSH terms:

Myocardial Ischemia
Coronary Artery Disease
Embolism
Ischemia
Heart Diseases
Cardiovascular Diseases

Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Embolism and Thrombosis
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012