SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

Coronary Artery Disease Clinical Trial

Official title: SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Status Completed

Clinical Trial Summary

The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V® arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston Scientific.

TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Clinical Trial Description

The completion of the SPIRIT IV clinical trial at three years is justified by the consistent long-term clinical evidence supporting the safety and efficacy of the XIENCE V EECSS in complex, real-world patients across multiple geographies. As SPIRIT IV was designed as a continued access trial, completing the clinical follow-up at the three-year visit does not conflict with any FDA requirements. Abbott Vascular is committed to providing clinical outcomes through three years. The clinical evidence provided from across multiple geographies, in complex populations thus supports Abbott Vascular's proposal to complete the SPIRIT IV RCT at the three-year clinical follow-up.

The SPIRIT IV Clinical Trial is a randomized, active-controlled, single-blinded, multicenter clinical trial in the US that will enroll approximately 3,690 subjects (2:1 randomization XIENCE V®: TAXUS®). The trial allows the treatment of up to three de novo native coronary artery lesions, maximum of two lesion per epicardial vessel, with reference vessel diameters (RVD) ≥ 2.5 mm to ≤ 4.25 mm and lesion lengths ≤ 28 mm. (NOTE: RVD ≥ 2.5 mm to ≤ 3.75 mm until 4.0 mm TAXUS® is commercially available). All subjects will be screened per the protocol inclusion and exclusion criteria and enrolled subjects will have clinical follow-up at 30, 180, and 270 days and 1, 2, and 3 years. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT00307047
• Study type: Interventional
• Source: Abbott Vascular
• Status: Completed
• Phase: Phase 3
• Start date: August 2006
• Completion date: May 2012