XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)

Study Overview
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Brief Summary
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This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) (CYPHER SELECT PLUS) during commercial use in China.

Detailed Description
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Objectives Confirm the safety and effectiveness of the XIENCE V EECSS for the treatment of patients in China Evaluate patient compliance with dual antiplatelet therapy (DAPT) Evaluate physician-determined XIENCE V EECSS acute performance, deliverability, and resource utilization

Official Title
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XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)

Conditions
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Coronary Occlusion, Thrombosis (Stent Thrombosis), Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis

Intervention / Treatment
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* Device: XIENCE V EECSS
* Device: CYPHER SELECT PLUS SECSS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria Patient must be at least 18 years of age The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee (EC)-approved ICF prior to procedure. Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up. Patient must not currently be and must agree not to become a participant in any other clinical trial until completion of his/her 2-year follow-up. Angiographic Inclusion Criteria Target lesion(s) must be located in a native de novo coronary artery with a visually estimated diameter between ≥ 2.25 and ≤ 4.0 mm. Target lesion(s) must measure ≤ 28 mm in length by visual estimation. A maximum of two de novo lesions can be treated, ie, One lesion in one vessel, OR One lesion in each of two vessels, OR Two lesions in one vessel Exclusion Criteria: General Exclusion Criteria Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year post index procedure Patients with known renal insufficiency or failure (eg, serum creatinine level of > 2.5 mg/dL, or patient is on dialysis) Patient had an MI within 72 hours and creatine kinase-myocardial band isoenzyme (CK-MB) has not returned to the normal range at the index procedure Non-study PCI for lesions in a target vessel (including side branches) has been performed within 1 year prior to the index procedure Patient has a planned PCI (staged procedure) within 6 months from the date of the index procedure Left ventricular ejection fraction (LVEF) of < 30%. Any planned surgery necessitating discontinuation of antiplatelet therapy within 1 year Patient's current medical condition has a life expectancy of < 2 years Patient meets contraindications of the IFU Angiographic Exclusion Criteria Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft Lesion located in left main coronary artery Ostial lesion (within 3 mm of the aorta junction, or origin of the left anterior descending or left circumflex arteries) Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimation Total occluded lesions (TIMI=0) Restenotic lesions Thrombus-containing vessel Extreme angulation (≥ 90º) proximal to or within the lesion Excessive tortuosity proximal to or within the lesion Heavy calcification

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: XIENCE V EECSS<br>Patients who will receive this stent. | Device: XIENCE V EECSS<br>* Patients who will receive this stent.<br>|
| Active Comparator: CYPHER SELECT PLUS SECSS<br>Patients who will receive this stent. | Device: CYPHER SELECT PLUS SECSS<br>* Patients who will receive this stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent Late Loss (LL) | This is the primary angiographic endpoint. In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent) | >=13 months | 
| Ischemia-driven Target Vessel Failure (ID-TVF) | This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR). | 12 months | 
| Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) | The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non-Q-wave). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia-driven Target Vessel Failure (ID-TVF) | Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]) | 30 days | 
| Ischemia-driven Target Vessel Failure (ID-TVF) | Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]). | 6 months | 
| Ischemia-driven Target Vessel Failure (ID-TVF) | Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]) | 9 months | 
| Ischemia-driven Target Vessel Failure (ID-TVF) | Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]) | 24 months | 
| Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave). |  | 30 days | 
| Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave). |  | 6 months | 
| Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) |  | 9 months | 
| Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) |  | 24 months | 
| Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) | The is the major Secondary Efficacy Endpoint. | 12 months | 
| Ischemia-driven Target Lesion Failure (ID-TLF) | Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR | 30 days | 
| Ischemia-driven Target Lesion Failure (ID-TLF) | Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR | 6 months | 
| Ischemia-driven Target Lesion Failure (ID-TLF) | This is one of the Secondary Composite Endpoints. | 9 months | 
| Ischemia-driven Target Lesion Failure (ID-TLF) | This is one of the Secondary Composite Endpoints. | 12 months | 
| Ischemia-driven Target Lesion Failure (ID-TLF) | This is one of the Secondary Composite Endpoints. | 24 months | 
| Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) |  | 30 days | 
| Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) |  | 6 months | 
| Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) |  | 9 months | 
| Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) |  | 12 months | 
| Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) |  | 24 months | 
| All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)]. | 30 days | 
| All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)]. | 6 months | 
| All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)]. | 9 months | 
| All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)]. | 12 months | 
| All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)]. | 24 months | 
| Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI |  | 30 days | 
| Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI |  | 6 months | 
| Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI |  | 9 months | 
| Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI |  | 12 months | 
| Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI |  | 24 months | 
| Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) |  | 30 days | 
| Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) |  | 6 months | 
| Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) |  | 9 months | 
| Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) |  | 12 months | 
| Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) |  | 24 months | 
| All Revascularization (TLR, TVR, and Non-TVR) |  | 30 Days | 
| All Revascularization (TLR, TVR, and Non-TVR) |  | 6 Months | 
| All Revascularization (TLR, TVR, and Non-TVR) |  | 9 Months | 
| All Revascularization (TLR, TVR, and Non-TVR) |  | 12 months | 
| All Revascularization (TLR, TVR, and Non-TVR) | One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG). | 24 months | 
| All Death | This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular. | 30 days | 
| All Death | This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular. | 6 months | 
| All Death | This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular. | 9 months | 
| All Death | This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular. | 12 months | 
| All Death | This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular. | 24 months | 
| All Protocol MI (Including Q-wave or Non-Q-wave) | This is one of the secondary safety endpoint. | 30 days | 
| All Protocol MI (Including Q-wave or Non-Q-wave) | This is one of the secondary safety endpoint. | 6 months | 
| All Protocol MI (Including Q-wave or Non-Q-wave) | This is one of the secondary safety endpoint. | 9 months | 
| All Protocol MI (Including Q-wave or Non-Q-wave) | This is one of the secondary safety endpoint. | 12 months | 
| All Protocol MI (Including Q-wave or Non-Q-wave) | This is one of the secondary safety endpoint. | 24 months | 
| Target Vessel Protocol MI (TV-MI) | This is one of the secondary safety endpoint. | 30 days | 
| Target Vessel Protocol MI (TV-MI) | This is one of the secondary safety endpoint. | 6 months | 
| Target Vessel Protocol MI (TV-MI) | This is one of the secondary safety endpoint. | 9 months | 
| Target Vessel Protocol MI (TV-MI) | This is one of the secondary safety endpoint. | 12 months | 
| Target Vessel Protocol MI (TV-MI) | This is one of the secondary safety endpoint. | 24 months | 
| Major Bleeding Complications | Secondary safety endpoint. | 30 days | 
| Major Bleeding Complications | Secondary safety endpoint. | 6 months | 
| Major Bleeding Complications | Secondary safety endpoint. | 9 months | 
| Major Bleeding Complications | Secondary safety endpoint. | 12 months | 
| Major Bleeding Complications | Secondary safety endpoint. | 24 months | 
| Definite / Probable Stent Thrombosis | Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation. | Acute (<1 day) | 
| Definite / Probable Stent Thrombosis | Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation. | Subacute (1 - 30 days) | 
| Definite / Probable Stent Thrombosis | Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation. | Early (0 - 30 days) | 
| Definite / Probable Stent Thrombosis | Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation. | Late (31 - 365 days) | 
| Definite / Probable Stent Thrombosis | Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation. | Very late (366 - 772 days) | 
| Definite / Probable Stent Thrombosis | Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation. | Overall (0 - 772 days) | 
| Patient Compliance With Dual Antiplatelet Therapy (DAPT) |  | 30 days | 
| Patient Compliance With Dual Antiplatelet Therapy (DAPT) |  | 6 months | 
| Patient Compliance With Dual Antiplatelet Therapy (DAPT) |  | 9 months | 
| Patient Compliance With Dual Antiplatelet Therapy (DAPT) |  | 12 months | 
| Patient Compliance With Dual Antiplatelet Therapy (DAPT) |  | 24 months | 
| Acute Device Success | Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of < 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction. | < or = 1 day | 
| Acute Procedure Success | Per-protocol procedure success is defined as the achievement of a final in-stent DS of < 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non-Q-wave), or repeat revascularization of the target lesion during the hospital stay. | < or = 1 day | 
| Procedure Time | This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter. | On day 0, during the procedure. | 
| Amount of Contrast Used | Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter. | On day 0, during the procedure. | 
| Fluoroscopy Time | This is the procedure related endpoint. | On day 0, during the procedure. | 
| XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire | A related secondary performance goal for XIENCE V EECSS is the physician-determined evaluation of acute performance, deliverability, and resource utilization. XIENCE V EECSS acute performance and deliverability were determined using the XIENCE V EECSS Performance Evaluation Questionnaire. Possible responses included strongly agree,moderately agree, agree, moderately disagree, and strongly disagree. Study physicians who enrolled patients into the study were reported for this outcome measure. | During the procedure | 
| Follow-up Late Loss | This is one of the Secondary Angiographic Endpoint. | ≥13 months. | 
| Follow-up In-stent Minimum Lumen Diameter (MLD) |  | ≥13 months | 
| Follow-up In-stent Percent Diameter Stenosis (DS) |  | ≥13 months | 
| Follow-up In-stent Angiographic Binary Restenosis (ABR) |  | ≥13 months | 
| Follow-up In-segment Minimum Lumen Diameter (MLD) |  | ≥13 months | 
| Follow-up In-segment Percent Diameter Stenosis (DS) |  | ≥13 months | 
| Follow-up In-segment Angiographic Binary Restenosis (ABR) |  | ≥13 months | 
| Percent Diameter Stenosis |  | pre procedure | 
| Percent Diameter Stenosis (%DS) |  | post procedure on 0 day | 
| Acute Gain |  | post procedure on 0 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug eluting stents, Stents, Angioplasty