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A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT) (ABSORB CHINA)

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ClinicalTrials.gov Identifier: NCT01923740
Recruitment Status : Active, not recruiting
First Posted : August 16, 2013
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Coronary Artery Disease
Coronary Artery Stenosis
Coronary Disease
Coronary Stenosis
Interventions: Device: XIENCE V EECSS
Device: Absorb BVS System

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The enrollment of the ABSORB China RCT began on July 31, 2013 & completed on March 13, 2014 with the first subject randomized on 2 August 2013. A total of 480 subjects (Intent-to-treat (ITT) population) were randomized (Absorb BVS:241&XIENCE:239) at 24 clinical sites in mainland China. The last subject completed the 1 year follow-up on May 7, 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 480 ITT subjects, 21 were excluded from the PTE population due to pre-specified protocol/treatment deviations or due to subject withdrawal prior to any study device attempts during the index procedure. Thus, of the 459 subjects in the PTE population, 227 were randomized to the Absorb BVS arm and 232 were randomized to the XIENCE V arm

Reporting Groups
  Description
Absorb BVS System Absorb BVS System: Subjects receiving Absorb BVS System
XIENCE V EECSS XIENCE V EECSS: Subjects receiving XIENCE V

Participant Flow for 4 periods

Period 1:   30-day Clinical Follow-up
    Absorb BVS System   XIENCE V EECSS
STARTED   227 [1]   232 [1] 
COMPLETED   227   232 
NOT COMPLETED   0   0 
[1] Per-treatment-evaluable (PTE) population

Period 2:   180-day Clinical Follow-up
    Absorb BVS System   XIENCE V EECSS
STARTED   227   232 
COMPLETED   227   232 
NOT COMPLETED   0   0 

Period 3:   270-day Clinical Follow-up
    Absorb BVS System   XIENCE V EECSS
STARTED   227   232 
COMPLETED   227   228 
NOT COMPLETED   0   4 
Death                0                4 

Period 4:   1 Year Clinical Follow-up
    Absorb BVS System   XIENCE V EECSS
STARTED   227   228 
COMPLETED   227   228 
NOT COMPLETED   0   0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Absorb BVS System Absorb BVS System: Subjects receiving Absorb BVS System
XIENCE V EECSS XIENCE V EECSS: Subjects receiving XIENCE V
Total Total of all reporting groups

Baseline Measures
   Absorb BVS System   XIENCE V EECSS   Total 
Overall Participants Analyzed 
[Units: Participants]
 227   232   459 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.1  (11.4)   57.7  (9.6)   57.4  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      66  29.1%      61  26.3%      127  27.7% 
Male      161  70.9%      171  73.7%      332  72.3% 
Region of Enrollment 
[Units: Participants]
     
China   228   232   460 


  Outcome Measures

1.  Primary:   In-segment Late Loss (LL) - Per Subject Analysis   [ Time Frame: At 1 year ]

2.  Primary:   In-segment Late Loss (LL) - Per Lesion Analysis   [ Time Frame: At 1 year ]

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

4.  Secondary:   Number of Participants With Acute Procedural Success   [ Time Frame: At time of procedure up to 7 days in hospital ]

5.  Secondary:   Number of Participants Experiencing Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

6.  Secondary:   Number of Participants Experiencing Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 0 to 37days ]

7.  Secondary:   Number of Participants Experiencing Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 0 to 208 days ]

8.  Secondary:   Number of Participants Experiencing Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 0 to 298 days ]

9.  Secondary:   Number of Participants Experiencing Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 0 to 393 days ]

10.  Secondary:   Number of Participants With Myocardial Infarction   [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

11.  Secondary:   Number of Participants With Myocardial Infarction   [ Time Frame: 0 to 37 days ]

12.  Secondary:   Number of Participants With Myocardial Infarction   [ Time Frame: 0 to 208 days ]

13.  Secondary:   Number of Participants With Myocardial Infarction   [ Time Frame: 0 to 298 days ]

14.  Secondary:   Number of Participants With Myocardial Infarction   [ Time Frame: 0 to 393 days ]

15.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

16.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: 0 to 37 days ]

17.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: 0 to 208 days ]

18.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: 0 to 298 days ]

19.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: 0 to 393 days ]

20.  Secondary:   Number of Participants With Target Vessel Revascularization (TVR)   [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

21.  Secondary:   Number of Participants With Target Vessel Revascularization (TVR)   [ Time Frame: 0 to 37 days ]

22.  Secondary:   Number of Participants With Target Vessel Revascularization (TVR)   [ Time Frame: 0 to 208 days ]

23.  Secondary:   Number of Participants With Target Vessel Revascularization (TVR)   [ Time Frame: 0 to 298 days ]

24.  Secondary:   Number of Participants With Target Vessel Revascularization (TVR)   [ Time Frame: 0 to 393 days ]

25.  Secondary:   Number of Participants With All Coronary Revascularization (PCI and CABG)   [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

26.  Secondary:   Number of Participants With All Coronary Revascularization (PCI and CABG)   [ Time Frame: 0 to 37days ]

27.  Secondary:   Number of Participants With All Coronary Revascularization (PCI and CABG)   [ Time Frame: 0 to 208 days ]

28.  Secondary:   Number of Participants With All Coronary Revascularization (PCI and CABG)   [ Time Frame: 0 to 298 Days ]

29.  Secondary:   Number of Participants With All Coronary Revascularization (PCI and CABG)   [ Time Frame: 0 to 393 Days ]

30.  Secondary:   Number of Participants Experiencing Death/All MI   [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

31.  Secondary:   Number of Participants Experiencing Death/All MI   [ Time Frame: 0 to 37 days ]

32.  Secondary:   Number of Participants Experiencing Death/All MI   [ Time Frame: 0 to 208 days ]

33.  Secondary:   Number of Participants Experiencing Death/All MI   [ Time Frame: 0 to 298 days ]

34.  Secondary:   Number of Participants Experiencing Death/All MI   [ Time Frame: 0 to 393 days ]

35.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI   [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

36.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI   [ Time Frame: 0 to 37 days ]

37.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI   [ Time Frame: 0 to 208 days ]

38.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI   [ Time Frame: 0 to 298 days ]

39.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI   [ Time Frame: 0 to 393 Days ]

40.  Secondary:   Number of Participants Experiencing All Death/All MI/All Revascularization (DMR)   [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

41.  Secondary:   Number of Participants Experiencing All Death/All MI/All Revascularization (DMR)   [ Time Frame: 0 to 37 days ]

42.  Secondary:   Number of Participants Experiencing All Death/All MI/All Revascularization (DMR)   [ Time Frame: 0 to 208 days ]

43.  Secondary:   Number of Participants Experiencing All Death/All MI/All Revascularization (DMR)   [ Time Frame: 0 to 298 days ]

44.  Secondary:   Number of Participants Experiencing All Death/All MI/All Revascularization (DMR)   [ Time Frame: 0 to 393 days ]

45.  Secondary:   Number of Participants Experiencing Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]   [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

46.  Secondary:   Number of Participants Experiencing Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]   [ Time Frame: 0 to 37 days ]

47.  Secondary:   Number of Participants Experiencing Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]   [ Time Frame: 0 to 208 days ]

48.  Secondary:   Number of Participants Experiencing Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]   [ Time Frame: 0 to 298 days ]

49.  Secondary:   Number of Participants Experiencing Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]   [ Time Frame: 0 to 393 Days ]

50.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]   [ Time Frame: ≤ 7 days post index procedure (In-hospital) ]

51.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]   [ Time Frame: 0 to 37 days ]

52.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]   [ Time Frame: 0 to 208 days ]

53.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]   [ Time Frame: 0 to 298 days ]

54.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]   [ Time Frame: 0 to 393 days ]

55.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])   [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

56.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])   [ Time Frame: 0 to 37 days ]

57.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])   [ Time Frame: 0 to 208 days ]

58.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])   [ Time Frame: 0 to 298 days ]

59.  Secondary:   Number of Participants Experiencing Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])   [ Time Frame: 0 to 393 days ]

60.  Secondary:   Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition)   [ Time Frame: < or = 1 day ]

61.  Secondary:   Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition)   [ Time Frame: >1 to 30 days ]

62.  Secondary:   Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)   [ Time Frame: 31 to 365 days ]

63.  Secondary:   Number of Participants With Overall Stent/Scaffold Thrombosis (Per ARC Definition)   [ Time Frame: 0 to 365 days ]

64.  Secondary:   In-Segment Minimum Lumen Diameter (MLD)   [ Time Frame: At 1 year ]

65.  Secondary:   In-Device Minimum Lumen Diameter (MLD)   [ Time Frame: At 1 year ]

66.  Secondary:   Proximal Minimum Lumen Diameter (MLD)   [ Time Frame: At 1 year ]

67.  Secondary:   Distal Minimum Lumen Diameter (MLD)   [ Time Frame: At 1 year ]

68.  Secondary:   In-Segment Percent Diameter Stenosis (%DS)   [ Time Frame: At 1 year ]

69.  Secondary:   In-Device Percent Diameter Stenosis (%DS)   [ Time Frame: At 1 year ]

70.  Secondary:   Proximal Percent Diameter Stenosis (%DS)   [ Time Frame: At 1 year ]

71.  Secondary:   Distal Percent Diameter Stenosis (%DS)   [ Time Frame: At 1 year ]

72.  Secondary:   In-Segment Angiographic Binary Restenosis (ABR)   [ Time Frame: At 1 year ]

73.  Secondary:   In-Device Angiographic Binary Restenosis (ABR)   [ Time Frame: At 1 year ]

74.  Secondary:   Proximal Angiographic Binary Restenosis (ABR)   [ Time Frame: At 1 year ]

75.  Secondary:   Distal Angiographic Binary Restenosis (ABR)   [ Time Frame: At 1 year ]

76.  Secondary:   In-Segment Late Loss (LL)   [ Time Frame: At 1 year ]

77.  Secondary:   In-Device Late Loss (LL)   [ Time Frame: At 1 year ]

78.  Secondary:   Proximal Late Loss (LL)   [ Time Frame: At 1 year ]

79.  Secondary:   Distal Late Loss (LL)   [ Time Frame: At 1 year ]

80.  Secondary:   Number of Participants Experiencing Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

81.  Secondary:   Number of Participants Experiencing Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

82.  Secondary:   Number of Participants Experiencing Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

83.  Secondary:   Number of Participants Experiencing Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

84.  Secondary:   Number of Participants With Myocardial Infarction   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

85.  Secondary:   Myocardial Infarction   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

86.  Secondary:   Myocardial Infarction   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

87.  Secondary:   Myocardial Infarction   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

88.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

89.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

90.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

91.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

92.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

93.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

94.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

95.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

96.  Secondary:   All Coronary Revascularization (PCI and CABG)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

97.  Secondary:   All Coronary Revascularization (PCI and CABG)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

98.  Secondary:   All Coronary Revascularization (PCI and CABG)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

99.  Secondary:   All Coronary Revascularization (PCI and CABG)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

100.  Secondary:   Death/All MI   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

101.  Secondary:   Death/All MI   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

102.  Secondary:   Death/All MI   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

103.  Secondary:   Death/All MI   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

104.  Secondary:   Cardiac Death/All MI   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

105.  Secondary:   Cardiac Death/All MI   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

106.  Secondary:   Cardiac Death/All MI   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

107.  Secondary:   Cardiac Death/All MI   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

108.  Secondary:   All Death/All MI/All Revascularization (DMR)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

109.  Secondary:   All Death/All MI/All Revascularization (DMR)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

110.  Secondary:   All Death/All MI/All Revascularization (DMR)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

111.  Secondary:   All Death/All MI/All Revascularization (DMR)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

112.  Secondary:   Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

113.  Secondary:   Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

114.  Secondary:   Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

115.  Secondary:   Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

116.  Secondary:   Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

117.  Secondary:   Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

118.  Secondary:   Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

119.  Secondary:   Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

120.  Secondary:   Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

121.  Secondary:   Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

122.  Secondary:   Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

123.  Secondary:   Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Karine Piard-Ruster, Principal Scientist Clinical Research
Organization: Abbott Vascular
phone: +1 408-845-0764
e-mail: karine.piard-ruster@abbott.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01923740     History of Changes
Other Study ID Numbers: 12-397
First Submitted: July 25, 2013
First Posted: August 16, 2013
Results First Submitted: January 16, 2018
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018