XIENCE V: SPIRIT WOMEN Sub-study

Study Overview
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Brief Summary
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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
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SPIRIT Women Randomized Sub-study is a prospective, single-blind, double arm, randomized multi-center sub-study comparing the XIENCE V® EECSS and XIENCE PRIME™ EESS to the CYPHER SELECT™ PLUS Sirolimus-eluting Coronary Stent in the treatment of female patients with coronary artery lesions. 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.

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

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

Intervention / Treatment
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* Device: XIENCE V®/ XIENCE PRIME™
* Device: CYPHER SELECT


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria: Patient must be female. Patient must be at least 18 years of age. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives and she or 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. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia). Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. Patient must agree to undergo all protocol-required follow-up examinations. Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment. Angiographic Inclusion Criteria: Patients' artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned study stents. Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy). Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate. The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available. Target lesion greater than or equal to 28 mm in length by visual estimate. General Exclusion Criteria: Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year). Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days. Patient who is judged to have a lesion that prevents complete inflation of an angioplasty balloon. Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) within the target vessel(s)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: XIENCE V® / XIENCE PRIME™<br> | Device: XIENCE V®/ XIENCE PRIME™<br>* Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System<br>|
| Active Comparator: CYPHER SELECT<br> | Device: CYPHER SELECT<br>* XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). | This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure. | at 1 year | 
| In-stent Late Loss (LL) (Main Secondary Endpoint) | In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up. | at 270 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Device Success | Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system. | Intra-operative | 
| Clinical Procedure Success | Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events. | Intra-operative | 
| Adjudicated Stent Thrombosis (Definite, Probable) |  | < 1 day (Acute) | 
| Adjudicated Stent Thrombosis (Definite, Probable) |  | 1 to 30 days (Sub-Acute) | 
| Adjudicated Stent Thrombosis (Definite, Probable) |  | 30 days to 1 year (Late) | 
| Adjudicated Stent Thrombosis (Definite, Probable, Possible) |  | 30 days to 1 year (Late) | 
| Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR). |  | at 30 days | 
| Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. |  | at 240 days | 
| Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. |  | at 1 year | 
| Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). |  | at 30 days | 
| Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). |  | at 240 days | 
| Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). |  | at 30 days | 
| Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). |  | at 240 days | 
| Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). |  | at 1 year | 
| Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). |  | at 30 days | 
| Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). |  | at 240 days | 
| Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). |  | at 1 year | 
| In-segment Late Loss (LL) | LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up | at 270 days | 
| In-stent Angiographic Binary Restenosis Rates | Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA). | at 270 days | 
| In-segment Angiographic Binary Restenosis Rates | Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA). | at 270 days | 
| In-stent Percent Diameter Stenosis |  | at 270 days | 
| In-segment Percent Diameter Stenosis |  | at 270 days | 
| Adjudicated Revascularization (TLR/TVR/All Revascularizations) | Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations | at 30 days | 
| Adjudicated Revascularization (TLR/TVR/All Revascularizations) | Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations | at 240 days | 
| Adjudicated Revascularization (TLR/TVR/All Revascularizations) | Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations | at 1 year | 
| Aneurysm | All subjects with aneurysm of the target lesion up to the 270 day follow-up visit | at 270 days | 
| Thrombus | All subjects with thrombus of the target lesion up to the 270 day follow-up visit | at 270 days | 
| Persisting Dissection | All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit | at 270 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stents, Angioplasty, Total coronary occlusions, Coronary restenosis, Stent thrombosis, Everolimus