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

Phase 4

Completed

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

Interventions: Device: CYPHER SELECT PLUS SECSS
Device: XIENCE V EECSS

Registration Number: NCT01178268

Lead Sponsor: Abbott Medical Devices

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 546

Inclusion Criteria

General Inclusion Criteria
1. Patient must be at least 18 years of age
2. 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.
3. Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up.
4. 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,
1. One lesion in one vessel, OR
2. One lesion in each of two vessels, OR
3. Two lesions in one vessel

Exclusion Criteria

General Exclusion Criteria
1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year post index procedure
2. Patients with known renal insufficiency or failure (eg, serum creatinine level of > 2.5 mg/dL, or patient is on dialysis)
3. 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
4. Non-study PCI for lesions in a target vessel (including side branches) has been performed within 1 year prior to the index procedure
5. Patient has a planned PCI (staged procedure) within 6 months from the date of the index procedure
6. Left ventricular ejection fraction (LVEF) of < 30%.
7. Any planned surgery necessitating discontinuation of antiplatelet therapy within 1 year
8. Patient's current medical condition has a life expectancy of < 2 years
9. 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYPHER SELECT PLUS SECSS	CYPHER SELECT PLUS SECSS	Patients who will receive this stent.
XIENCE V EECSS	XIENCE V EECSS	Patients who will receive this stent.

Primary Outcome Measures

Name	Time	Method
Ischemia-driven Target Vessel Failure (ID-TVF)	12 months	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).
In-stent Late Loss (LL)	>=13 months	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)
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)	12 months	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).

Secondary Outcome Measures

Name	Time	Method
Acute Gain	post procedure on 0 day
Follow-up In-segment Minimum Lumen Diameter (MLD)	≥13 months
Follow-up Late Loss	≥13 months.	This is one of the Secondary Angiographic Endpoint.
Follow-up In-segment Percent Diameter Stenosis (DS)	≥13 months
Follow-up In-segment Angiographic Binary Restenosis (ABR)	≥13 months
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)	24 months	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) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].
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)	24 months
Procedure Time	On day 0, during the procedure.	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.
Fluoroscopy Time	On day 0, during the procedure.	This is the procedure related endpoint.
Ischemia-driven Target Vessel Failure (ID-TVF)	24 months	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 \[PCI and CABG\])
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
Ischemia-driven Target Lesion Failure (ID-TLF)	24 months	This is one of the Secondary Composite Endpoints.
Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])	12 months	The is the major Secondary Efficacy Endpoint.
All Protocol MI (Including Q-wave or Non-Q-wave)	24 months	This is one of the secondary safety endpoint.
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
Patient Compliance With Dual Antiplatelet Therapy (DAPT)	24 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 Revascularization (TLR, TVR, and Non-TVR)	24 months	One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).
Target Vessel Protocol MI (TV-MI)	24 months	This is one of the secondary safety endpoint.
Major Bleeding Complications	24 months	Secondary safety endpoint.
Amount of Contrast Used	On day 0, during the procedure.	Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.
XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire	During the procedure	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.
Percent Diameter Stenosis (%DS)	post procedure on 0 day
All Death	24 months	This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Definite / Probable Stent Thrombosis	Overall (0 - 772 days)	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 Device Success	< or = 1 day	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.
Acute Procedure Success	< or = 1 day	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.
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
Percent Diameter Stenosis	pre procedure

Trial Locations

Locations (2): Fu Wai Hospital
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Beijing, China
Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.
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Shanghai, China