SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe

SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions

The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.

The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Sub-Study and the Registry.

The SPIRIT V Registry is a prospective, single arm, multi-center registry evaluating performance of the XIENCE V® EECSS in real-world use, per its Instruction For Use (IFU). 2,700 patients will be enrolled in the SPIRIT V Registry.

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 V Registry study after 2 years.

Inclusion Criteria:

• at least 18 years
• able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
• evidence of myocardial ischemia
• acceptable candidate for coronary artery bypass graft (CABG) surgery
• undergo all CIP-required follow-up examinations
• artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned XIENCE V® EESCC
• target lesions must be de novo lesions
• target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
• target lesion ≤ 28 mm in length by visual estimate

Exclusion Criteria:

Patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.