The Optical Coherence Tomography Drug Eluting Stent Investigation

The Optical Coherence Tomography Drug Eluting Stent Investigation(OCTDESI)

The objective of this study is to evaluate the completeness of struts coverage and vessel wall response to the new generation JACTAX drug-eluting stent vs Taxus stent in de novo coronary artery lesions at 6 months post index procedure. To investigate the completeness of the coverage as well as the number of uncovered stent struts per section, high resolution (~ 10-15 µm axial) intracoronary Optical Coherence Tomography (OCT) will be used.

The risk of late stent thrombosis represents a major concern for patients treated with first generation drug-eluting stents (DES). Delayed healing and poor endothelialization are common findings in vessels treated with DES and are probably related to the amount of drug and polymer applied to a DES. There is evidence to suggest that polymer applications may influence the processes of inflammation and vessel healing. The JACTAX family of DES have been designed to provide a maximum amount of drug delivered directly to coronary vessel tissue while excluding polymer and drug from contact within the vessel lumen. The JACTAX stents are comprised of a currently marketed bare metal stent (Libertè™) coated exclusively on the ablumenal stent surface with a carrier containing a bioerodable polymer, Polylactide and paclitaxel. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the JACTAX stents vs Taxus Libertè in de novo coronary artery lesions at 6 months post index procedure. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.

Inclusion Criteria:

General Inclusion Criteria

1. Patient is ≥ 18 years of age
2. Patient is eligible for percutaneous coronary intervention (PCI)
3. Patient demonstrates a left ventricular ejection fraction (LVEF) of ≥ 25%
4. Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect.

Angiographic Inclusion Criteria

1. Target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated) ≤ 25 mm that can be treated with a single JACTAX, JACTAX LD or TAXUS stent
2. A second lesion in a second vessel may be treated with one (1) TAXUS™ Libertè™ DES or a bare metal stent.

Exclusion Criteria:

General Exclusion Criteria

1. The patient has a life expectancy of less than 24 months due to another medical condition
2. Patient has a history of hypersensitivity to paclitaxel or structurally related compounds
3. Patient exhibits cardiogenic shock (systolic pressure < 80mm Hg and PCWP > 20mm Hg or cardiac index <1.8 liters/minute/m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure>80 mm Hg) for any time within 24 hours prior to index procedure
4. Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine > 2.0 mg/dl or177 µmol/l)
5. Planned cardiac surgery procedure ≤ 6 months post-index procedure
6. Patient demonstrates evidence of a acute myocardial infarction (eg. STEMI or enzyme elevation CK > 2X local laboratory's ULN unless CK-MB is < 2X ULN) 7) Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months
7. Patient demonstrates evidence of leukopenia (leukocyte count < 3.5 X 109/liter)
8. Patient demonstrates evidence of thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (>750,000/mm3)
9. Patient is contraindicated to ASA (successful prior desensitization to ASA is not an exclusion), clopidogrel, or ticlopidine
10. Patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
11. Patient has been treated with paclitaxel or other chemotherapeutic agents within 12-months prior to planned index procedure
12. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 6-months after the index procedure
13. Patient has received a drug eluting stent within 12-months prior to planned index procedure
14. Previous or planned treatment with intravascular brachytherapy in target vessel
15. Known allergy to stainless steel
16. Female or male with known intention to procreate within 3 months after the index procedure (due to the exposure to paclitaxel and unknown affect it may have on the fetus)
17. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 9 months post index procedure
18. Patient that in the opinion of the investigator is not clinically appropriate for OCT evaluation.

Angiographic Exclusion Criteria

1. Evidence of thrombus of the study vessel, based on angiography or IVUS
2. Study lesion is totally occluded (TIMI flow ≤ 1) either at baseline or before pre-dilatation
3. Study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified, by visual estimate
4. Study lesion is ostial in location (within 3.0 mm of vessel origin)
5. Study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a >60 degree bend in the vessel
6. Study lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel > 2.0 mm in diameter
7. Left main coronary artery disease (stenosis >50%) whether protected or unprotected
8. Target lesion length > 25 mm, based on visual estimate by operator
9. Target vessel diameter > 3.5 mm, based on visual estimate by operator
10. Target vessel diameter < 2.75 mm based on visual estimate by operator
11. Pre-treatment of the target lesion (excluding predilation) with another interventional device.