• 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 ]
  

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

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.

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.

Inclusion Criteria:

• Candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting and emergent coronary artery bypass graft (CABG).
• Total CK and CK-MB verified to be within hospital normal limits at the time of enrollment.

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

  • Diagnosis at time of enrollment of stable or unstable angina pectoris
  • Reversible 12-lead electrocardiogram (ECG) changes consistent with ischemia
  • Positive functional study (e.g. stress test)
  • Recent myocardial infarction ( > 24 hours prior to enrollment with total CK and CK-MB verified to be within hospital normal limits at the time of enrollment).
• Lesion(s) is located within SVG and is ≥ 50% and < 100% stenosed. The patient may have one or two SVG grafts to be treated and each SVG may have more than one lesion.
• Vessel has thrombolysis in myocardial infarction (TIMI) Grade 1 or higher flow before or after the passage of a non-study guidewire.
• Reference vessel diameter where the FiberNet filter device is to be placed is ≥ 1.75 mm and ≤ 7.0 mm in diameter by careful visual estimation.
• Lesion(s) can be treated/pre-treated with PTCA balloons and/or stent only (cutting balloon is allowed).
• The investigator determines that all branch vessels distal to the target lesion and proximal to the proposed site of device deployment will be adequately protected.

Exclusion Criteria:

Clinical Criteria:

• Known allergy to heparin and bivalirudin (Angiomax).
• 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.
• Anatomical exclusions that preclude placement of the FiberNet device per the Instructions for Use.
• 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).
• Procedural complication prior to introduction of the FiberNet device into the body.