Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

French Multicenter Study Assessing Angioplasty With Taxus Drug Eluting Stent in Unprotected Left Main Coronary Artery Associated to Other Coronary Lesions or Not

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00300157

Enrollment

155

Registered

2006-03-08

Start date

2005-12-31

Completion date

2010-01-31

Last updated

2011-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Arteriosclerosis

Keywords

Left main coronary artery stenosis, stent, Taxus, Unprotected left main coronary artery disease, Percutaneous coronary intervention with Taxus stent

Brief summary

The purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not.

Detailed description

Coronary artery bypass graft is the reference treatment of left main coronary artery disease. With the advancements of technology and particularly drug-eluting stents, in-stent restenosis has dramatically decreased and now it is possible to extend indications of complexes lesions such as left main coronary artery stenoses. In these particular situations,some centers performed percutaneous coronary angioplasty (PCI) with drug-eluting stents with acceptable results in terms of safety and efficacy. However, these procedures are performed at isolated sites and are not evaluated in multicenter trial.The aim of this study is to assess the safety and efficacy of this PCI with Taxus-stent in a french multicenter trial and to evaluate clinical and angiographic outcome of these patients at long-term follow-up.

Interventions

DEVICEPercutaneous coronary intervention with Taxus stent

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The patient must be \> or = 18 years of age * Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee * Aspirin + Clopidogrel \> or = 12 hours before percutaneous coronary intervention (PCI) * Documented evidence of ischemic heart disease (clinical,biological or ECG) with unprotected left main coronary artery stenosis \> or = 50% associated to other coronary lesions or not responsible of stable or unstable coronary syndrome above 48 hours * The target reference vessel diameter must be \> or = 2.5 mm * Unprotected left main coronary artery disease eligible by coronary stenting

Exclusion criteria

* Restenosis lesion in left main coronary artery * Known allergies to the following: aspirin, clopidogrel,ticlopidine,contrast agent or drug similar to paclitaxel * Acute coronary syndrome \< 48 hours * Impaired renal function (creatinine \> 180 ùmol/l) at the time of treatment * Life expectancy less than 36 months * Female of childbearing potential without reliable birth control * Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints

Design outcomes

Primary

Measure	Time frame
Coronarography	9 months

Secondary

Measure	Time frame
Major cardio-vascular events	1, 18 and 36 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026