Small Coronary Artery Treated by TAXUS Liberté Registry in Japan (SACRA)

Society for Advancement of Coronary Intervention Research

Status and phase: Unknown; Phase 4

Conditions: Unstable Angina Pectoris; Stable Angina Pectoris

Treatments: Device: TAXUS Liberté paclitaxel-eluting coronary stent system

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00955214

SACRA1

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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) -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

2.5mm Paclitaxel-eluting stent

Experimental group

Treatment:

Device: TAXUS Liberté paclitaxel-eluting coronary stent system