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

Abbott Medical Devices2 sites in 1 country546 target enrollmentAugust 2010

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

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Occlusion
Sponsor: Abbott Medical Devices
Enrollment: 546
Locations: 2
Primary Endpoint: Ischemia-driven Target Vessel Failure (ID-TVF)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

September 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Ischemia-driven Target Vessel Failure (ID-TVF)

Time Frame: 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)

Time Frame: >=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)

Time Frame: 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 Outcomes

Acute Gain(post procedure on 0 day)
Follow-up Late Loss(≥13 months.)
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)
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.)
Fluoroscopy Time(On day 0, during the procedure.)
Ischemia-driven Target Vessel Failure (ID-TVF)(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).(6 months)
Ischemia-driven Target Lesion Failure (ID-TLF)(24 months)
All Protocol MI (Including Q-wave or Non-Q-wave)(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)(24 months)
Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])(12 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)
Target Vessel Protocol MI (TV-MI)(24 months)
Major Bleeding Complications(24 months)
Amount of Contrast Used(On day 0, during the procedure.)
XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire(During the procedure)
Percent Diameter Stenosis (%DS)(post procedure on 0 day)
All Death(24 months)
Definite / Probable Stent Thrombosis(Overall (0 - 772 days))
Acute Device Success(< or = 1 day)
Acute Procedure Success(< or = 1 day)
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)
Percent Diameter Stenosis(pre procedure)