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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01178268
First received: August 6, 2010
Last updated: December 13, 2013
Last verified: December 2013

August 6, 2010
December 13, 2013
August 2010
October 2012   (final data collection date for primary outcome measure)
  • In-stent late loss (LL) [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    In-stent LL: in-stent Minimal Lumen Diameter (MLD) post procedure - in-stent MLD at follow-up
  • Ischemia-driven target vessel failure (ID-TVF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI and ischemia-driven target vessel revascularization (ID-TVR)
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01178268 on ClinicalTrials.gov Archive Site
  • ID target vessel failure (ID-TVF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI and ID-TVR
  • ID target vessel failure (ID-TVF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI and ID-TVR
  • ID target vessel failure (ID-TVF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI, and ID-TVR
  • ID target vessel failure (ID-TVF) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI, and ID-TVR
  • ID 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
  • ID 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
  • ID target lesion failure (ID-TLF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
  • ID target lesion failure (ID-TLF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Patient compliance with DAPT [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy
  • Patient compliance with DAPT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy
  • Patient compliance with DAPT [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy
  • Patient compliance with DAPT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy
  • Patient compliance with DAPT [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy
  • Major bleeding complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Acute device success [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Achievement of a final in-stent residual diameter stenosis of <50% using only the assigned device and without device malfunction.
  • XIENCE V EECSS acute performance and deliverability using the XIENCE V EECSS Performance Evaluation Questionnaire [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Procedure time [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Fluoroscopy time [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Amount of contrast used [ Time Frame: 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.
  • ID target lesion failure (ID-TLF) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
  • Acute procedure success [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Achievement of a final in-stent residual diameter stenosis of <50% using the assigned device and with any adjunctive devices and without cardiac death, MI or TVR.
  • Composite of all death, all MI, and all revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • ID target vessel failure (ID-TVF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI and ID-TVR
  • ID target vessel failure (ID-TVF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI and ID-TVR
  • ID target vessel failure (ID-TVF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI, and ID-TVR
  • ID target vessel failure (ID-TVF) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI, and ID-TVR
  • ID 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
  • ID 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
  • ID target lesion failure (ID-TLF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
  • ID target lesion failure (ID-TLF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Patient compliance with DAPT [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy
  • Patient compliance with DAPT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy
  • Patient compliance with DAPT [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy
  • Patient compliance with DAPT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy
  • Patient compliance with DAPT [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy
  • Major bleeding complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Acute device success [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Achievement of a final in-stent residual diameter stenosis of <50% using only the assigned device and without device malfunction.
  • XIENCE V EECSS acute performance and deliverability using the XIENCE V EECSS Performance Evaluation Questionnaire [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Procedure time [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Fluoroscopy time [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Amount of contrast used [ Time Frame: 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.
  • ID target lesion failure (ID-TLF) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
  • Acute procedure success [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Achievement of a final in-stent residual diameter stenosis of <50% using the assigned device and with any adjuctive devices and without cardiac death, MI or TVR.
  • Composite of all death, all MI, and all revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Coronary Occlusion
  • Stent Thrombosis
  • Vascular Disease
  • Myocardial Ischemia
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis
  • Device: XIENCE V EECSS
    Patients who will receive this stent.
  • Device: CYPHER SELECT PLUS SECSS
    Patients who will receive this stent.
  • Active Comparator: XIENCE V EECSS
    Patients who will receive this stent.
    Intervention: Device: XIENCE V EECSS
  • Active Comparator: CYPHER SELECT PLUS SECSS
    Patients who will receive this stent.
    Intervention: Device: CYPHER SELECT PLUS SECSS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
546
February 2014
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01178268
10-387
No
Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: Gao Runlin, MD, FACC Fu Wai Hospital
Abbott Vascular
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP