SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

Study Overview
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Brief Summary
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Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System. TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Detailed Description
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The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies. In this study, 300 subjects (3:1 randomization XIENCE V® EECSS: TAXUS™ PECSS were enrolled at 31 sites outside the United States. The primary endpoint was in-stent late loss at 6 months. Secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and IVUS results at 6 months and 2 years. Follow-up through 3 years is currently available.

Official Title
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A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native 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
* Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: De novo Target lesion(s) must be located in a native epicardial vessel with diameter between 2.25 mm and 4.25 mm by visual estimate The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a TIMI flow of >= 1 Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure or if planned to be done > 9 months after the index procedure Exclusion Criteria: De novo target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure Target lesion(s) restenotic from previous intervention Target lesion(s) located in a major epicardial vessel that has been previously treated with brachytherapy Target vessel(s) contains visible thrombus Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy) Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


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;|
| Active Comparator: 2<br>TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent | Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent<br>* Drug eluting stent implantation stent in the treatment of coronary artery disease<br>* Other names: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent late loss (LL) |  | at 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment Late Loss |  | at 180 days (all patients) and at 2 years (for a subset of 152 patients) | 
| In-stent Late Loss at 2 years (for a subset of 152 patients) |  | at 2 years (for a subset of 152 patients) | 
| Proximal and distal Late Loss |  | at 180 days (all patients) and at 2 years (for a subset of 152 patients) | 
| In-stent and in-segment Angiographic Binary Restenosis (ABR) rate |  | at 180 days (all patients) and at 2 years (for a subset of 152 patients) | 
| In-stent and in-segment percent Diameter Stenosis (% DS) |  | at 180 days (all patients) and at 2 years (for a subset of 152 patients) | 
| In-stent percent Volume Obstruction (% VO) |  | at 180 days and at 2 years for a subset of 152 patients | 
| Plaque behind the stent( by IVUS) |  | at 180 days and at 2 years for a subset of 152 patients | 
| Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate |  | at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years | 
| Ischemia Driven Target Vessel Failure (ID-TVF) |  | at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years | 
| Ischemia Driven Target Lesion Revascularization (ID-TLR) |  | at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years | 
| Persisting incomplete stent apposition, late-acquired incomplete stent apposition |  | at 180 days and at 2 years for a subset of 152 patients | 
| Aneurysm, thrombosis and persisting dissection |  | at 180 days (all patients) and at 2 years (for a subset of 152 patients) | 
| Acute success(device, procedure and clinical) |  | 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