JACTAX LD Drug Eluting Stent Trial
JACTAX LD Drug Eluting Stent Trial
Prospective, multi-center, randomized trial. A maximum of 130 patients will be enrolled, in a
 2:1 ratio to receive either the JACTAX LD stent or the TAXUS™ Libertè™ stent to evaluate the
 efficacy of the product.
The JACTAX Drug Eluting Stent has been designed to minimize the amount of polymer in contact
 with the vessel surface, thus potentially reducing the incidence of untoward side effects.
 The Juxtaposed Ablumenal Coating Process is capable of exclusive coating on the ablumenal
 side of pre-mounted bare metal stents. Juxtaposed Ablumenal Coating is a proprietary
 formulation containing a bioerodable polymer. The combination of the Juxtaposed Ablumenal
 Coating Process and Juxtaposed Ablumenal Coating create a unique microstructure surface, and
 reduces the amount of required polymer.
General Inclusion Criteria:

 1. Patient is ≥ 18 years of age

 2. Patient with coronary artery disease, eligible for percutaneous coronary intervention
 (PCI)

 3. Patient demonstrates a 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)

 2. The target lesion can be treated with a maximum of one stent, with adequate coverage
 onto the healthy tissue, as specified in visual estimate guidelines. Maximum lesion
 length is 20mm.

 3. The reference vessel diameter is between 2.75mm and 3.5mm

 4. Study lesion diameter stenosis is ≥70% (visual estimate) and <100% and a TIMI flow >1.

 5. Study lesion has been successfully pre-dilated

 6. Patients enrolled for treatment may demonstrate multiple lesions in target vessel.
 However lesions must be covered completely by one study stent.

 7. Patient must have no more than two lesions requiring treatments. These lesions must be
 in different vessel distributions. For example, if the target lesion is in the LAD,
 then the non target lesion must be present in either the circumflex or RCA. The
 non-study lesion may not be in a branch vessel or distal to the target vessel
 location.

 8. The non target lesion must be successfully treated prior to the treatment of the
 target lesion. The non target lesion must be treated with a TAXUS paclitaxel eluting
 stent or a bare metal stainless steel stent.

 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 <80mmHg and PCWP >20mmHg or
 cardiac index <1.8 liters/minute/m or intra-aortic balloon pump or intravenous
 inotropes are needed to maintain a systolic pressure >80mmHg) 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 or 177 umol/l)

 5. Planned cardiac surgery procedure <= 9 months post index procedure

 6. Patient demonstrates evidence of myocardial infarction (elevated CK, CKMB or Troponin)
 within 72 hours prior to the index procedure and/or CK >2X local lab's ULN, unless
 CK-MB is < 2X ULN

 7. Patient exhibits acute ST segment elevation MI within 72 hours prior to the index
 procedure

 8. CVA including stroke or TIA within previous 3 months

 9. Patient demonstrates evidence of leukopenia

 10. Patient demonstrates evidence of thrombocytopenia or thrombocytosis

 11. Patient is contraindicated to ASA, clopidogrel or ticlopidine

 12. Patient is currently taking warfarin or possibility of treatment with warfarin during
 the following 6 months post index procedure

 13. Patient has been treated with paclitaxel or other chemotherapeutic agents within 12
 months prior to planned index procedure

 14. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9
 months after the index procedure

 15. Patient has received a drug eluting stent within 12 months prior to planned index
 procedure

 16. Previous or planned treatment with intravascular brachytherapy in target vessel

 17. Known allergy to stainless steel

 18. Male or female with known intention to procreate within 3 months after the index
 procedure

 19. 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

 Angiographic Exclusion Criteria

 1. Evidence of probable or definite thrombus of the study vessel, based on angiography or
 IVUS

 2. Study lesion is totally occluded (TIMI flow <= 1)either at baseline or before
 predilatation

 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 >20mm based on visual estimate by operator

 9. Target vessel diameter >3.5mm 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