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

Sponsor

Lumen Biomedical (Industry)

Overall Status

Completed

CT.gov ID

NCT00453518

Collaborator

(none)

Enrollment

Locations

23.1

Duration (Months)

4.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Saphenous Vein Graft Disease Myocardial Ischemia Embolism	Device: FiberNet EPS used during SVG intervention.	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Outcome Measures

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. [30 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Munroe Regional Medical Center	Ocala	Florida	United States	34474
2	St. Vincent Hospital	Indianapolis	Indiana	United States	46290
3	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
4	Christ Hospital	Cincinnati	Ohio	United States	45219
5	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
6	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18105