Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEJACTAX LD DES
Drug Eluting Stent
DEVICETAXUS™ Libertè™ DES
Drug Eluting Stent
Sponsors
Labcoat, Ltd.
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE rate at 9 months | 9 months |
Countries
Germany
Outcome results
None listed