A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems (GENESIS)

A Randomized, Multi-Center Study of the Pimecrolimus-Eluting (Corio™) and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System (SymBio™) in Patients With De Novo Lesions of the Native Coronary Arteries

To demonstrate non-inferiority in 6-month angiographic in-stent late lumen loss of the pimecrolimus-eluting coronary stent (Corio) compared to the CoStar coronary stent control arm and the dual pimecrolimus/paclitaxel-eluting (Symbio) coronary stent compared to the CoStar coronary stent control arm for the treatment of single de novo lesions <25 mm in length in native coronary arteries 2.5 - 3.5 mm in diameter.

This study is designed to evaluate 6 month in-stent late lumen loss of the 1) Corio™ pimecrolimus-eluting coronary stent system and the 2) SymBio™ dual pimecrolimus/paclitaxel-eluting coronary stent system compared to the CoStar™ Paclitaxel-Eluting Coronary Stent System control arm.

Inclusion Criteria:

General Inclusion Criteria

1. Eligible for percutaneous coronary intervention (PCI).
2. Documented stable or unstable angina pectoris
3. Left ventricular ejection fraction (LVEF) ≥25%
4. Acceptable candidate for coronary artery bypass graft surgery (CABG).
5. Target lesion < 25 mm in length with RVD of ≥2.5 mm to ≤3.5 mm with visually estimated stenosis of ≥50% and < 100% .
6. Target vessel had not undergone prior revascularization within the preceding 6 months.
7. Target lesion must have been a minimum of 10 mm distance from any previously treated segment of the target vessel
8. Patient understood the study requirements and the treatment procedures and provided written Informed Consent, approved by the local Ethics Committee.
9. Willing to comply with all specified follow-up evaluations.

Exclusion Criteria:

General Exclusion Criteria

1. Known sensitivity to pimecrolimus, paclitaxel, the polymer (PLGA) or cobalt chromium.
2. Planned treatment with any other PCI device in the target vessel(s).
3. MI within 72 hours prior to the index procedure
4. The patient is in cardiogenic shock.
5. Cerebrovascular Accident (CVA) within the past 6 months.
6. Acute or chronic renal dysfunction
7. Contraindication to ASA or to clopidogrel.
8. Thrombocytopenia
9. Active gastrointestinal (GI) bleeding within the past 3 months.
10. Any prior true anaphylactiod reaction to contrast agents
11. Patient is currently taking colchicine, chronic systemic steroid therapy or systemic immunosuppressant therapy, or or had been treated with paclitaxel (systemic) within 12 months of the index procedure.
12. Patient was currently, or was on long term intermittent therapy with topical pimecrolimus
13. Female of childbearing potential.
14. Life expectancy of less than 24 months due to other medical conditions.
15. Co-morbid condition(s)
16. Currently participating in another investigational drug or device study

General Angiographic Exclusion Criteria:

1. Left main coronary artery disease (stenosis >50%), whether protected or unprotected.
2. Target lesion was ostial in location (within 3.0 mm of vessel origin).
3. Target lesion and/or target vessel proximal to the target lesion was severely calcified by visual estimation.
4. Target lesion involved a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter that required intervention.
5. Target lesion was totally occluded Thrombolysis In MI (TIMI flow 0) or TIMI flow ≤1.
6. Angiographic presence of probable or definite thrombus.
7. Target vessel would have been pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement.
8. Prior coronary intervention using brachytherapy to any segment of the target vessel.
9. The target vessel had prior drug-eluting stent placement to vessel segment (or branch) proximal to intended target lesion site within preceding 6 months.
10. Angiographic restenosis of any segment of the target vessel that had undergone prior percutaneous coronary intervention.
11. Angiographic evidence of atherosclerotic disease with >50% diameter stenosis (by visual estimate) proximal or distal to the target lesion (applies to the major epicardial portion of the target vessel and contiguous vessel segment if the target lesion was located in a branch vessel).
12. Prior surgical revascularization of the target vessel with patent graft (saphenous vein graft or arterial conduit).
13. Target lesion lied within 10mm of prior surgical anastomosis site.