Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

Coronary Arteriosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300157
• Other study ID #: 2004-06
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2006
• Last updated: January 3, 2011
• Start date: December 2005
• Est. completion date: January 2010

Study information

• Verified date: January 2011
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Device:
• Percutaneous coronary intervention with Taxus stent

Locations

Country	Name	City	State
France	Polyclinique du Parc Rambot	Aix-en-Provence
France	Clinique Rhône Durance	Avignon
France	Clinique Saint Augustin	Bordeaux
France	Chu Brest	Brest
France	CHU CAEN	CAEN Cedex
France	Hôpital Cardiologique	Lille
France	Clinique du Tonkin	Lyon
France	CHU NORD	Marseille
France	Unité Cardio-Vasculaire	Marseille
France	Institut Hospitalier Jacques Cartier-ICPS	Massy
France	Hôpital Bon Secours	Metz
France	Clinique du Millénaire	Montpellier
France	Nouvelles Cliniques Nantaises	Nantes
France	CHU Caremeau	Nimes
France	Hôpital privé Les Franciscaines	Nimes
France	Groupe Hospitalier La Pitié-Salpetrière	Paris
France	Hôpital COCHIN	Paris
France	Institut Mutualiste Montsouris	Paris
France	CHU Pontchaillou	Rennes
France	Clinique Saint Hilaire	Rouen
France	Hôpital Charles Nicolle	Rouen
France	Institut Arnaud Tzanck	Saint Laurent du Var
France	Centre Cardiologique du Nord	Saint-Denis
France	CHU Toulouse Rangueil	Toulouse
France	Clinique Pasteur	Toulouse
France	Clinique Saint Gatien	Tours

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	Boston Scientific Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronarography		9 months
Secondary	Major cardio-vascular events		1, 18 and 36 months