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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Coronary Occlusion; Thrombosis (Stent Thrombosis); Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis
Interventions:	Device: XIENCE V EECSS; Device: CYPHER SELECT PLUS SECSS

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 488 patients in the Per-protocol (PP) population for final analysis. First Patient Enrolled on August 18, 2010, Last Patient Enrolled on August 31, 2011 and the Final Database Lock was on September 26, 2013. The total patient enrollment rate was 0.5 patients/site/week based on 489 patients enrolled over 54 weeks at 20 sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All of the 546 patients, 57 (28:XIENCE;29:CYPHER)were excluded from the Per-protocol (PP) population, leaving a baseline population of 489 patients. Whereas because of patient disposition results in a total of 488 patients in the PP population for final analysis.

Reporting Groups

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

Participant Flow:   Overall Study

	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
STARTED	367	121
COMPLETED	360	120
NOT COMPLETED	7	1

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All of the 546 patients, 57 were excluded from the Per-protocol (PP) population, leaving a baseline population of 489 patients and a total of 488 patients (Based on angiographic follow-up) in the PP population for final analysis. In which 367 were randomized to receive XIENCE V EECSS and 121 to CYPHER SELECT Plus SECSS group.

Reporting Groups

	Description
XIENCE V EECSS	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.
CYPHER SELECT PLUS SECSS	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Total	Total of all reporting groups

Baseline Measures

	XIENCE V EECSS	CYPHER SELECT PLUS SECSS	Total
Overall Participants Analyzed; [Units: Participants]	367	121	488
Age; [Units: Years]; Mean (Standard Deviation)	58.60 (10.65)	58.74 (9.12)	58.64 (10.28)
Age, Customized; [Units: Participants]
Age ≥ 65 years	95	33	128
Age < 65 years	272	88	360
Gender; [Units: Participants]
Female	95	40	135
Male	272	81	353
Race/Ethnicity, Customized; [Units: Participants]
Chinese	367	121	488
Region of Enrollment; [Units: Participants]
China	367	121	488

  Outcome Measures

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1. Primary:

In-stent Late Loss (LL) [ Time Frame: >=13 months ]

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2. Primary:

Ischemia-driven Target Vessel Failure (ID-TVF) [ Time Frame: 12 months ]

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3. Primary:

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 ]

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4. Secondary:

Ischemia-driven Target Vessel Failure (ID-TVF) [ Time Frame: 30 days ]

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5. Secondary:

Ischemia-driven Target Vessel Failure (ID-TVF) [ Time Frame: 6 months ]

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6. Secondary:

Ischemia-driven Target Vessel Failure (ID-TVF) [ Time Frame: 9 months ]

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7. Secondary:

Ischemia-driven Target Vessel Failure (ID-TVF) [ Time Frame: 24 months ]

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8. Secondary:

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 ]

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9. Secondary:

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 ]

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10. Secondary:

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 ]

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11. Secondary:

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 ]

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12. Secondary:

Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 12 months ]

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13. Secondary:

Ischemia-driven Target Lesion Failure (ID-TLF) [ Time Frame: 30 days ]

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14. Secondary:

Ischemia-driven Target Lesion Failure (ID-TLF) [ Time Frame: 6 months ]

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15. Secondary:

Ischemia-driven Target Lesion Failure (ID-TLF) [ Time Frame: 9 months ]

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16. Secondary:

Ischemia-driven Target Lesion Failure (ID-TLF) [ Time Frame: 12 months ]

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17. Secondary:

Ischemia-driven Target Lesion Failure (ID-TLF) [ Time Frame: 24 months ]

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18. Secondary:

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 ]

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19. Secondary:

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 ]

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20. Secondary:

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 ]

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21. Secondary:

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 ]

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22. Secondary:

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 ]

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23. Secondary:

All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [ Time Frame: 30 days ]

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24. Secondary:

All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [ Time Frame: 6 months ]

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25. Secondary:

All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [ Time Frame: 9 months ]

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26. Secondary:

All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [ Time Frame: 12 months ]

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27. Secondary:

All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [ Time Frame: 24 months ]

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28. Secondary:

Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [ Time Frame: 30 days ]

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29. Secondary:

Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [ Time Frame: 6 months ]

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30. Secondary:

Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [ Time Frame: 9 months ]

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31. Secondary:

Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [ Time Frame: 12 months ]

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32. Secondary:

Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [ Time Frame: 24 months ]

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33. Secondary:

Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [ Time Frame: 30 days ]

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34. Secondary:

Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [ Time Frame: 6 months ]

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35. Secondary:

Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [ Time Frame: 9 months ]

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36. Secondary:

Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [ Time Frame: 12 months ]

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37. Secondary:

Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [ Time Frame: 24 months ]

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38. Secondary:

All Revascularization (TLR, TVR, and Non-TVR) [ Time Frame: 30 Days ]

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39. Secondary:

All Revascularization (TLR, TVR, and Non-TVR) [ Time Frame: 6 Months ]

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40. Secondary:

All Revascularization (TLR, TVR, and Non-TVR) [ Time Frame: 9 Months ]

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41. Secondary:

All Revascularization (TLR, TVR, and Non-TVR) [ Time Frame: 12 months ]

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42. Secondary:

All Revascularization (TLR, TVR, and Non-TVR) [ Time Frame: 24 months ]

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43. Secondary:

All Death [ Time Frame: 30 days ]

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44. Secondary:

All Death [ Time Frame: 6 months ]

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45. Secondary:

All Death [ Time Frame: 9 months ]

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46. Secondary:

All Death [ Time Frame: 12 months ]

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47. Secondary:

All Death [ Time Frame: 24 months ]

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48. Secondary:

All Protocol MI (Including Q-wave or Non–Q-wave) [ Time Frame: 30 days ]

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49. Secondary:

All Protocol MI (Including Q-wave or Non–Q-wave) [ Time Frame: 6 months ]

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50. Secondary:

All Protocol MI (Including Q-wave or Non–Q-wave) [ Time Frame: 9 months ]

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51. Secondary:

All Protocol MI (Including Q-wave or Non–Q-wave) [ Time Frame: 12 months ]

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52. Secondary:

All Protocol MI (Including Q-wave or Non–Q-wave) [ Time Frame: 24 months ]

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53. Secondary:

Target Vessel Protocol MI (TV-MI) [ Time Frame: 30 days ]

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54. Secondary:

Target Vessel Protocol MI (TV-MI) [ Time Frame: 6 months ]

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55. Secondary:

Target Vessel Protocol MI (TV-MI) [ Time Frame: 9 months ]

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56. Secondary:

Target Vessel Protocol MI (TV-MI) [ Time Frame: 12 months ]

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57. Secondary:

Target Vessel Protocol MI (TV-MI) [ Time Frame: 24 months ]

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58. Secondary:

Major Bleeding Complications [ Time Frame: 30 days ]

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59. Secondary:

Major Bleeding Complications [ Time Frame: 6 months ]

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60. Secondary:

Major Bleeding Complications [ Time Frame: 9 months ]

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61. Secondary:

Major Bleeding Complications [ Time Frame: 12 months ]

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62. Secondary:

Major Bleeding Complications [ Time Frame: 24 months ]

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63. Secondary:

Definite / Probable Stent Thrombosis [ Time Frame: Acute (<1 day) ]

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64. Secondary:

Definite / Probable Stent Thrombosis [ Time Frame: Subacute (1 – 30 days) ]

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65. Secondary:

Definite / Probable Stent Thrombosis [ Time Frame: Early (0 – 30 days) ]

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66. Secondary:

Definite / Probable Stent Thrombosis [ Time Frame: Late (31 – 365 days) ]

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67. Secondary:

Definite / Probable Stent Thrombosis [ Time Frame: Very late (366 – 772 days) ]

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68. Secondary:

Definite / Probable Stent Thrombosis [ Time Frame: Overall (0 - 772 days) ]

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69. Secondary:

Patient Compliance With Dual Antiplatelet Therapy (DAPT) [ Time Frame: 30 days ]

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70. Secondary:

Patient Compliance With Dual Antiplatelet Therapy (DAPT) [ Time Frame: 6 months ]

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71. Secondary:

Patient Compliance With Dual Antiplatelet Therapy (DAPT) [ Time Frame: 9 months ]

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72. Secondary:

Patient Compliance With Dual Antiplatelet Therapy (DAPT) [ Time Frame: 12 months ]

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73. Secondary:

Patient Compliance With Dual Antiplatelet Therapy (DAPT) [ Time Frame: 24 months ]

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74. Secondary:

Acute Device Success [ Time Frame: < or = 1 day ]

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75. Secondary:

Acute Procedure Success [ Time Frame: < or = 1 day ]

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76. Secondary:

Procedure Time [ Time Frame: On day 0, during the procedure. ]

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77. Secondary:

Amount of Contrast Used [ Time Frame: On day 0, during the procedure. ]

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78. Secondary:

Fluoroscopy Time [ Time Frame: On day 0, during the procedure. ]

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79. Secondary:

XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire [ Time Frame: During the procedure ]

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80. Secondary:

Follow-up Late Loss [ Time Frame: ≥13 months. ]

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81. Secondary:

Follow-up In-stent Minimum Lumen Diameter (MLD) [ Time Frame: ≥13 months ]

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82. Secondary:

Follow-up In-stent Percent Diameter Stenosis (DS) [ Time Frame: ≥13 months ]

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83. Secondary:

Follow-up In-stent Angiographic Binary Restenosis (ABR) [ Time Frame: ≥13 months ]

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84. Secondary:

Follow-up In-segment Minimum Lumen Diameter (MLD) [ Time Frame: ≥13 months ]

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85. Secondary:

Follow-up In-segment Percent Diameter Stenosis (DS) [ Time Frame: ≥13 months ]

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86. Secondary:

Follow-up In-segment Angiographic Binary Restenosis (ABR) [ Time Frame: ≥13 months ]

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87. Secondary:

Percent Diameter Stenosis [ Time Frame: pre procedure ]

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88. Secondary:

Percent Diameter Stenosis (%DS) [ Time Frame: post procedure on 0 day ]

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89. Secondary:

Acute Gain [ Time Frame: post procedure on 0 day ]

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90. Other Pre-specified:

ID-TVF Rate in Patients With Diabetic Disease [ Time Frame: 24 months ]

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91. Other Pre-specified:

ID-TVF Rate in Patients Without Diabetic Disease [ Time Frame: 24 months ]

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92. Other Pre-specified:

ID-TVF Rate in Single Lesion Treated Subgroup [ Time Frame: 24 months ]

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93. Other Pre-specified:

ID-TVF Rate in Dual Lesion Treated Subgroup [ Time Frame: 24 months ]

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94. Other Pre-specified:

ID-TVF Rate in Single Vessel Treated Subgroup [ Time Frame: 24 months ]

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95. Other Pre-specified:

ID-TVF Rate in Dual Vessel Treated Subgroup [ Time Frame: 24 months ]

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96. Other Pre-specified:

The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease. [ Time Frame: 24 months ]

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97. Other Pre-specified:

The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease [ Time Frame: 24 months ]

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98. Other Pre-specified:

The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup [ Time Frame: 24 months ]

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99. Other Pre-specified:

The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup [ Time Frame: 24 months ]

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100. Other Pre-specified:

The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup [ Time Frame: 24 months ]

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101. Other Pre-specified:

The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup [ Time Frame: 24 months ]

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102. Other Pre-specified:

ID-TLR Rate in Patients With Diabetic Disease. [ Time Frame: 24 months ]

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103. Other Pre-specified:

ID-TLR Rate in Patients Without Diabetic Disease [ Time Frame: 24 months ]

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104. Other Pre-specified:

ID-TLR Rate in Single Lesion Treated Subgroup [ Time Frame: 24 months ]

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105. Other Pre-specified:

ID-TLR Rate in Dual Lesion Treated Subgroup [ Time Frame: 24 months ]

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106. Other Pre-specified:

ID-TLR Rate in Single Vessel Treated Subgroup [ Time Frame: 24 months ]

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107. Other Pre-specified:

ID-TLR Rate in Dual Vessel Treated Subgroup [ Time Frame: 24 months ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  

Name/Title: Dana Haudek
Organization: Abbott Vascular
phone: 928-925-4054
e-mail: dana.haudek@av.abbott.com

Responsible Party:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT01178268 History of Changes
Other Study ID Numbers:	10-387
First Submitted:	August 6, 2010
First Posted:	August 10, 2010
Results First Submitted:	May 17, 2016
Results First Posted:	August 24, 2016
Last Update Posted:	August 24, 2016