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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Coronary Disease, Coronary Artery Disease, Coronary Restenosis

Intervention / Treatment
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* Device: XIENCE V® Everolimus Eluting Coronary Stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>XIENCE V® Everolimus Eluting Coronary Stent System | Device: XIENCE V® Everolimus Eluting Coronary Stent<br>* Drug eluting stent implantation stent in the treatment of coronary artery disease.<br>* Other names: XIENCE V® Everolimus Eluting Coronary Stent System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) . |  | at 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPIRIT V Registry: Acute Success (Clinical Procedure Success) |  | Acute | 
| SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible) |  | at 30 days, 1 and 2 years | 
| SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization) |  | at 30 days, 1 and 2 years | 
| SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR |  | at 30 days, 1 and 2 years | 
| SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR |  | at 30 days, 1 and 2 years | 
| SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR) |  | at 30 days, 1 and 2 years | 
| SPIRIT V Registry: Acute Success (Clinical Device Success) |  | Acute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting stents, stents, Angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis