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

Myocardial Ischemia Clinical Trial

— RETRIEVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453518
• Other study ID #: 90-1004
• Status: Completed
• Phase: N/A
• First received: March 28, 2007
• Last updated: August 17, 2009
• Start date: March 2007
• Est. completion date: February 2009

Study information

• Verified date: August 2009
• Source: Lumen Biomedical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Embolism
• Myocardial Ischemia
• Saphenous Vein Graft Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Christ Hospital	Cincinnati	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	Munroe Regional Medical Center	Ocala	Florida
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Lumen Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints.		index hospitalization	Yes

External Links

•   Lumen Biomedical website