Use of the GARDEX™ Embolic Protection Device During Percutaneous Coronary Interventions of Saphenous Vein Graft

Phase I Study to Demonstrate the Safety and Performance of the GARDEX™ Embolic Protection Device When Used During Percutaneous Coronary Intervention (PCI) of Saphenous Vein Graft

This is a multi center, prospective study designed to demonstrate the safety and performance of the GARDEX Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) interventions.

Inclusion Criteria:

• Anticipated patient life expectancy of at least 1 year from enrollment.

• Patient (or their legal guardian) has provided a signed informed consent.

• Patient is willing to comply with the protocol requirements.

• Candidate for PCI, stenting and CABG.

• Total CK 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 ECG changes consisted with ischemia
  • Positive function study (e.g. stress test)
  • Recent myocardial infarction (>24 hours prior to enrollment with total CK verified to be within hospital normal limits at the time of enrollment).

• Lesions amendable to PCI.

• Lesion(s) is located within SVG and has ≥50% and <100% stenosis (angiographic visual assessment).

• Only single SVG graft to be treated.

• Vessel has thrombolysis in myocardial infarction (TIMI) grade 1 or higher flow before the passage of a guidewire.

• Reference vessel diameter where the GARDEX™ system is to be placed is ≥ 3.5mm and ≤6.0mm in diameter by angiographic visual estimation.

Exclusion Criteria:

• A hypersensitivity or contraindication to heparin and bivalirum (Angiomax), aspirin, ticlopidine, clopidogrel, murine products, procedure equipment material, and a sensitivity to contrast dye which cannot be adequately pre-treated with diphenhydramine and/or steroids.
• Myocardial infarction with documented total CK> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
• A stroke or transient ischemic attach (TIA) within the past 2 months.
• A history of bleeding diathesis or coagulopathy.
• Major gastrointestinal (GI) bleeding within 3 months of index procedure.
• Baseline creatinine ≥ 2.5 mg/dl.
• A planned invasive surgical procedure within 30 days.
• Undergone cardiac surgery within the past 60 days.
• The lesion is in a SVG that is less than 2 months post implant.
• Left ventricular ejection fraction < 20%
• The lesion is an arterial conduit.
• Anatomical exclusions that preclude placement of the GARDEX™ system per the Instruction for Use.
• More than one SVG graft that need to be treated at the index procedure.
• Chronic occlusion of the target lesion/severe calcification.