Clinical Trials Directory

Trials / Completed

CompletedNCT00180453

SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System

SPIRIT First: A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Abbott Medical Devices · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Prospective, randomized, controlled, single-blinded, parallel two-arm, multicenter trial. Test arm: XIENCE V® Everolimus Eluting Coronary Stent System(stent length: 18mm, diameter: 3.0mm) Control arm: Metallic stent (MULTI-LINK VISION® metallic stent(stent length: 18mm, diameter: 3.0mm) Follow-up angiographic imaging and intra vascular ultra sound (IVUS) at 180 days and 1 year

Detailed description

The SPIRIT FIRST clinical trial will enroll approximately 60 patients and will assess the feasibility and performance of the XIENCE V® Everolimus Eluting Coronary Stent System in the treatment of patients with de novo native coronary artery lesions. In this trial, the XIENCE V® Everolimus Eluting Coronary Stent System will be compared to the MULTI-LINK VISION® metallic stent which is CE marked and FDA approved and is available for commercial use in Europe and in the United States. The SPIRIT FIRST Clinical trial will enroll approximately 60 patients (30 patients in the test arm and 30 patients in the control arm) with de novo native coronary artery lesions in 4 clinical sites in The Netherlands and Germany

Conditions

Interventions

TypeNameDescription
DEVICECoronary artery drug eluting stent placementCoronary artery drug eluting stent placement
DEVICECoronary artery stent placementCoronary artery stent placement

Timeline

Start date
2003-12-01
Primary completion
2005-04-01
Completion
2009-06-01
First posted
2005-09-16
Last updated
2010-01-06

Locations

7 sites across 3 countries: Denmark, Germany, Netherlands

Source: ClinicalTrials.gov record NCT00180453. Inclusion in this directory is not an endorsement.