NCT00496938

XIENCE V: SPIRIT WOMEN

A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,600 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

Detailed description

SPIRIT Women Single-Arm Study: A prospective, open label, single arm, multi-center study evaluating performance of the XIENCE V® and XIENCE PRIME™ EECSS in the treatment of female patients with coronary artery lesions, per its Instructions for Use (IFU). The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results. The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria. Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT Women study after 2 years.

Conditions

• Coronary Artery Stenosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Artery Restenosis
• Total Coronary Occlusion
• Stent Thrombosis
• Vascular Disease
• Myocardial Ischemia

Interventions

Type	Name	Description
DEVICE	XIENCE V®/ XIENCE PRIME™	Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-08-01
• Completion: 2011-07-01
• First posted: 2007-07-06
• Last updated: 2015-05-13

Locations

95 sites across 26 countries: Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, South Africa, Spain, Switzerland, United Kingdom, Venezuela