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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
Results First Received: May 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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
  Show All Outcome Measures

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

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

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 ]

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

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

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

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

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 ]

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 ]

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 ]

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 ]

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

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

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

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

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

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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

43.  Secondary:   All Death   [ Time Frame: 30 days ]

44.  Secondary:   All Death   [ Time Frame: 6 months ]

45.  Secondary:   All Death   [ Time Frame: 9 months ]

46.  Secondary:   All Death   [ Time Frame: 12 months ]

47.  Secondary:   All Death   [ Time Frame: 24 months ]

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

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

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

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

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

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

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

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

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

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

58.  Secondary:   Major Bleeding Complications   [ Time Frame: 30 days ]

59.  Secondary:   Major Bleeding Complications   [ Time Frame: 6 months ]

60.  Secondary:   Major Bleeding Complications   [ Time Frame: 9 months ]

61.  Secondary:   Major Bleeding Complications   [ Time Frame: 12 months ]

62.  Secondary:   Major Bleeding Complications   [ Time Frame: 24 months ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

87.  Secondary:   Percent Diameter Stenosis   [ Time Frame: pre procedure ]

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

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

90.  Other Pre-specified:   ID-TVF Rate in Patients With Diabetic Disease   [ Time Frame: 24 months ]

91.  Other Pre-specified:   ID-TVF Rate in Patients Without Diabetic Disease   [ Time Frame: 24 months ]

92.  Other Pre-specified:   ID-TVF Rate in Single Lesion Treated Subgroup   [ Time Frame: 24 months ]

93.  Other Pre-specified:   ID-TVF Rate in Dual Lesion Treated Subgroup   [ Time Frame: 24 months ]

94.  Other Pre-specified:   ID-TVF Rate in Single Vessel Treated Subgroup   [ Time Frame: 24 months ]

95.  Other Pre-specified:   ID-TVF Rate in Dual Vessel Treated Subgroup   [ Time Frame: 24 months ]

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

97.  Other Pre-specified:   The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease   [ Time Frame: 24 months ]

98.  Other Pre-specified:   The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup   [ Time Frame: 24 months ]

99.  Other Pre-specified:   The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup   [ Time Frame: 24 months ]

100.  Other Pre-specified:   The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup   [ Time Frame: 24 months ]

101.  Other Pre-specified:   The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup   [ Time Frame: 24 months ]

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

103.  Other Pre-specified:   ID-TLR Rate in Patients Without Diabetic Disease   [ Time Frame: 24 months ]

104.  Other Pre-specified:   ID-TLR Rate in Single Lesion Treated Subgroup   [ Time Frame: 24 months ]

105.  Other Pre-specified:   ID-TLR Rate in Dual Lesion Treated Subgroup   [ Time Frame: 24 months ]

106.  Other Pre-specified:   ID-TLR Rate in Single Vessel Treated Subgroup   [ Time Frame: 24 months ]

107.  Other Pre-specified:   ID-TLR Rate in Dual Vessel Treated Subgroup   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  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
Study First Received: August 6, 2010
Results First Received: May 17, 2016
Last Updated: July 14, 2016
Health Authority: China: Food and Drug Administration