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

Abbott Medical Devices546 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

546

Conditions

Coronary Occlusion Thrombosis (Stent Thrombosis)Vascular Disease Myocardial Ischemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 1. 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. 2. Target lesion(s) must measure ≤ 28 mm in length by visual estimation. 3. 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 1. Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft 2. Lesion located in left main coronary artery 3. Ostial lesion (within 3 mm of the aorta junction, or origin of the left anterior descending or left circumflex arteries) 4. 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 5. Total occluded lesions (TIMI=0) 6. Restenotic lesions 7. Thrombus-containing vessel 8. Extreme angulation (≥ 90º) proximal to or within the lesion 9. Excessive tortuosity proximal to or within the lesion 10. Heavy calcification

Locations (2)

Fu Wai Hospital

Beijing, China

Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.

Shanghai, China

Outcomes

Primary Outcomes

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)

Time frame: >=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).

Time frame: 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).

Time frame: 12 months

Secondary Outcomes

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 \[PCI and CABG\])

Time frame: 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 \[PCI and CABG\]).

Time frame: 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 \[PCI and CABG\])

Time frame: 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 \[PCI and CABG\])

Time frame: 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).

Time frame: 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).

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: 12 months

Ischemia-driven Target Lesion Failure (ID-TLF)

Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

Time frame: 30 days

Ischemia-driven Target Lesion Failure (ID-TLF)

Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

Time frame: 6 months

Ischemia-driven Target Lesion Failure (ID-TLF)

This is one of the Secondary Composite Endpoints.

Time frame: 9 months

Ischemia-driven Target Lesion Failure (ID-TLF)

This is one of the Secondary Composite Endpoints.

Time frame: 12 months

Ischemia-driven Target Lesion Failure (ID-TLF)

This is one of the Secondary Composite Endpoints.

Time frame: 24 months

Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)

Time frame: 30 days

Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)

Time frame: 6 months

Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)

Time frame: 9 months

Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)

Time frame: 12 months

Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)

Time frame: 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) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].

Time frame: 30 days

All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)

Time frame: 6 months

All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)

Time frame: 9 months

All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)

Time frame: 12 months

All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)

Time frame: 24 months

Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI

Time frame: 30 days

Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI

Time frame: 6 months

Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI

Time frame: 9 months

Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI

Time frame: 12 months

Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI

Time frame: 24 months

Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)

Time frame: 30 days

Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)

Time frame: 6 months

Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)

Time frame: 9 months

Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)

Time frame: 12 months

Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)

Time frame: 24 months

All Revascularization (TLR, TVR, and Non-TVR)

Time frame: 30 Days

All Revascularization (TLR, TVR, and Non-TVR)

Time frame: 6 Months

All Revascularization (TLR, TVR, and Non-TVR)

Time frame: 9 Months

All Revascularization (TLR, TVR, and Non-TVR)

Time frame: 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).

Time frame: 24 months

All Death

This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

Time frame: 30 days

All Death

This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

Time frame: 6 months

All Death

This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

Time frame: 9 months

All Death

This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

Time frame: 12 months

All Death

This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

Time frame: 24 months

All Protocol MI (Including Q-wave or Non-Q-wave)