Stable Angina Pectoris, Unstable Angina Pectoris
Conditions
Keywords
TAXUS Liberté, Small coronary artery disease, Paclitaxel-eluting stent
Brief summary
The utilization of paclitaxel-eluting coronary stents in small vessel diseases is effective in reducing both repeat revascularization and major adverse cardiac events within two year follow-up. To evaluate the procedural, short and long term clinical outcomes of the Taxus Liberte™ Paclitaxel-Eluting Coronary Stent in small coronary arteries of ≤ 2.5 mm in the reference vessel diameter.
Interventions
DEVICETAXUS Liberté paclitaxel-eluting coronary stent system
diameter is 2.5mm
Sponsors
Society for Advancement of Coronary Intervention Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥20 years and are able to undergo CABG 2. Females who are not pregnant 3. Patients who present with angina symptoms or myocardial ischemia 4. Patients available for post-procedural observation and coronary angiography at 24 months 5. Patients who have signed patient informed consent 6. Lesion which is eligible for only one 2.5mm paclitaxel-eluting stent 7. De novo lesion or non-stented restenosed lesion
Exclusion criteria
1. Patients contraindicated for antiplatelet therapy or anticoagulant therapy 2. Patients with significant allergic reaction to contrast medium 3. Chronic total occlusion 4. Lesion with TIMI0 5. Lesion which is needed more than two stents 6. Patients with chronic renal failure (SCr\>3.0mg/dl) -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion revascularization rate | within 9months |
Secondary
| Measure | Time frame |
|---|---|
| Technical success | initial |
| Target lesion revascularization rate | 12 months |
| Target vessel revascularization rate | 12 months |
| The rate of MACE including MI due to stent thrombosis | 12 months |
Countries
Japan
Outcome results
None listed