Coronary Artery Disease Clinical Trial
Official title:
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
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
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 ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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