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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01178268
First received: August 6, 2010
Last updated: July 14, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Coronary Occlusion
Thrombosis (Stent Thrombosis)
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: XIENCE V EECSS
Device: CYPHER SELECT PLUS SECSS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • In-stent Late Loss (LL) [ Time Frame: >=13 months ] [ Designated as safety issue: No ]

    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)


  • Ischemia-driven Target Vessel Failure (ID-TVF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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).

  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • Ischemia-driven Target Vessel Failure (ID-TVF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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])

  • Ischemia-driven Target Vessel Failure (ID-TVF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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]).

  • Ischemia-driven Target Vessel Failure (ID-TVF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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])

  • Ischemia-driven Target Vessel Failure (ID-TVF) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The is the major Secondary Efficacy Endpoint.

  • Ischemia-driven Target Lesion Failure (ID-TLF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

  • Ischemia-driven Target Lesion Failure (ID-TLF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

  • Ischemia-driven Target Lesion Failure (ID-TLF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    This is one of the Secondary Composite Endpoints.

  • Ischemia-driven Target Lesion Failure (ID-TLF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    This is one of the Secondary Composite Endpoints.

  • Ischemia-driven Target Lesion Failure (ID-TLF) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    This is one of the Secondary Composite Endpoints.

  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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)].

  • All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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)].

  • All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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)].

  • All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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)].

  • All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • All Revascularization (TLR, TVR, and Non-TVR) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • All Revascularization (TLR, TVR, and Non-TVR) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • All Revascularization (TLR, TVR, and Non-TVR) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • All Revascularization (TLR, TVR, and Non-TVR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • All Revascularization (TLR, TVR, and Non-TVR) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).

  • All Death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

  • All Death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

  • All Death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

  • All Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

  • All Death [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

  • All Protocol MI (Including Q-wave or Non-Q-wave) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint.

  • All Protocol MI (Including Q-wave or Non-Q-wave) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint.

  • All Protocol MI (Including Q-wave or Non-Q-wave) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint.

  • All Protocol MI (Including Q-wave or Non-Q-wave) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint.

  • All Protocol MI (Including Q-wave or Non-Q-wave) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint.

  • Target Vessel Protocol MI (TV-MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint.

  • Target Vessel Protocol MI (TV-MI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint.

  • Target Vessel Protocol MI (TV-MI) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint.

  • Target Vessel Protocol MI (TV-MI) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint.

  • Target Vessel Protocol MI (TV-MI) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    This is one of the secondary safety endpoint.

  • Major Bleeding Complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Secondary safety endpoint.

  • Major Bleeding Complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Secondary safety endpoint.

  • Major Bleeding Complications [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Secondary safety endpoint.

  • Major Bleeding Complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Secondary safety endpoint.

  • Major Bleeding Complications [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Secondary safety endpoint.

  • Definite / Probable Stent Thrombosis [ Time Frame: Acute (<1 day) ] [ Designated as safety issue: Yes ]
    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.

  • Definite / Probable Stent Thrombosis [ Time Frame: Subacute (1 - 30 days) ] [ Designated as safety issue: Yes ]
    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.

  • Definite / Probable Stent Thrombosis [ Time Frame: Early (0 - 30 days) ] [ Designated as safety issue: Yes ]
    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.

  • Definite / Probable Stent Thrombosis [ Time Frame: Late (31 - 365 days) ] [ Designated as safety issue: Yes ]
    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.

  • Definite / Probable Stent Thrombosis [ Time Frame: Very late (366 - 772 days) ] [ Designated as safety issue: Yes ]
    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.

  • Definite / Probable Stent Thrombosis [ Time Frame: Overall (0 - 772 days) ] [ Designated as safety issue: Yes ]
    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.

  • Patient Compliance With Dual Antiplatelet Therapy (DAPT) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Patient Compliance With Dual Antiplatelet Therapy (DAPT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient Compliance With Dual Antiplatelet Therapy (DAPT) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Patient Compliance With Dual Antiplatelet Therapy (DAPT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient Compliance With Dual Antiplatelet Therapy (DAPT) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Acute Device Success [ Time Frame: < or = 1 day ] [ Designated as safety issue: No ]
    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 [ Time Frame: < or = 1 day ] [ Designated as safety issue: No ]
    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.

  • Procedure Time [ Time Frame: On day 0, during the procedure. ] [ Designated as safety issue: No ]
    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.

  • Amount of Contrast Used [ Time Frame: On day 0, during the procedure. ] [ Designated as safety issue: No ]
    Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.

  • Fluoroscopy Time [ Time Frame: On day 0, during the procedure. ] [ Designated as safety issue: No ]
    This is the procedure related endpoint.

  • XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    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.

  • Follow-up Late Loss [ Time Frame: ≥13 months. ] [ Designated as safety issue: No ]
    This is one of the Secondary Angiographic Endpoint.

  • Follow-up In-stent Minimum Lumen Diameter (MLD) [ Time Frame: ≥13 months ] [ Designated as safety issue: No ]
  • Follow-up In-stent Percent Diameter Stenosis (DS) [ Time Frame: ≥13 months ] [ Designated as safety issue: No ]
  • Follow-up In-stent Angiographic Binary Restenosis (ABR) [ Time Frame: ≥13 months ] [ Designated as safety issue: No ]
  • Follow-up In-segment Minimum Lumen Diameter (MLD) [ Time Frame: ≥13 months ] [ Designated as safety issue: No ]
  • Follow-up In-segment Percent Diameter Stenosis (DS) [ Time Frame: ≥13 months ] [ Designated as safety issue: No ]
  • Follow-up In-segment Angiographic Binary Restenosis (ABR) [ Time Frame: ≥13 months ] [ Designated as safety issue: No ]
  • Percent Diameter Stenosis [ Time Frame: pre procedure ] [ Designated as safety issue: No ]
  • Percent Diameter Stenosis (%DS) [ Time Frame: post procedure on 0 day ] [ Designated as safety issue: No ]
  • Acute Gain [ Time Frame: post procedure on 0 day ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • ID-TVF Rate in Patients With Diabetic Disease [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    ID-TVF rate in All Diabetes patients.

  • ID-TVF Rate in Patients Without Diabetic Disease [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    ID-TVF rate in Non Diabetes

  • ID-TVF Rate in Single Lesion Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    ID-TVF rate in Patients with single lesion treated during the index procedure

  • ID-TVF Rate in Dual Lesion Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    ID-TVF rate in Patients with dual lesion treated during the index procedure

  • ID-TVF Rate in Single Vessel Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    ID-TVF rate in Patients with single vessels treated during the index procedure.

  • ID-TVF Rate in Dual Vessel Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    ID-TVF rate in Patients with dual vessel treated during the index procedure.

  • The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The composite of ST, all death, and all MI rate in All Diabetes patients.

  • The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The composite of ST, all death, and all MI rate in Non Diabetes

  • The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure

  • The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure

  • The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure.

  • The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure.

  • ID-TLR Rate in Patients With Diabetic Disease. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Ischemia-driven target lesion revascularization rate in All Diabetes patients.

  • ID-TLR Rate in Patients Without Diabetic Disease [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Ischemia-driven target lesion revascularization rate in Non Diabetes

  • ID-TLR Rate in Single Lesion Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure

  • ID-TLR Rate in Dual Lesion Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure

  • ID-TLR Rate in Single Vessel Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure.

  • ID-TLR Rate in Dual Vessel Treated Subgroup [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure.


Enrollment: 546
Study Start Date: August 2010
Study Completion Date: September 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: XIENCE V EECSS
Patients who will receive this stent.
Device: XIENCE V EECSS
Patients who will receive this stent.
Active Comparator: CYPHER SELECT PLUS SECSS
Patients who will receive this stent.
Device: CYPHER SELECT PLUS SECSS
Patients who will receive this stent.

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178268

Locations
China
Fu Wai Hospital
Beijing, China, 100037
Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.
Shanghai, China, 200122
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Gao Runlin, MD, FACC Fu Wai Hospital
  More Information

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01178268     History of Changes
Other Study ID Numbers: 10-387 
Study First Received: August 6, 2010
Results First Received: May 17, 2016
Last Updated: July 14, 2016
Health Authority: China: Food and Drug Administration

Keywords provided by Abbott Vascular:
Drug eluting stents
Stents
Angioplasty

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Thrombosis
Vascular Diseases
Coronary Stenosis
Coronary Restenosis
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Embolism and Thrombosis
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016