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ABSORB III Randomized Controlled Trial (RCT) (ABSORB-III)

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ClinicalTrials.gov Identifier: NCT01751906
Recruitment Status : Active, not recruiting
First Posted : December 18, 2012
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Coronary Artery Disease
Coronary Artery Stenosis
Coronary Disease
Coronary Stenosis
Interventions: Device: Absorb BVS
Device: XIENCE

  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 first Lead-In subject (Lead-In Group ) was registered on Dec 28, 2012. A total of 2008 patients (Primary Analysis Group) were randomized into Absorb (N=1322)/Xience (N=686) at 193 study sites between 22 March 2013 & 3 April 2014 comprising the Intent-to-Treat (ITT) population of the study & the last 1-year follow-up visit was on April 2, 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Of total 13,789 eligible population,11,781 patients were excluded due to,

  1. Not meeting general eligibility criteria only (n=567);
  2. Not meeting angiographic eligibility criteria only (n=10,690);
  3. Not meeting both 1 and 2 (n=64);
  4. Other reasons (n=460).

Reporting Groups
  Description
Absorb BVS

Subjects receiving Absorb BVS

Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm

  • Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
  • The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.

Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

XIENCE

Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition

XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).

  • Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
  • Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
  • For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices

To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.


Participant Flow:   Overall Study
    Absorb BVS   XIENCE
STARTED   1322   686 
COMPLETED   1313   677 
NOT COMPLETED   9   9 



  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

Subjects receiving Absorb BVS

Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm

  • Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
  • The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.

Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

XIENCE

Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition

XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).

  • Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
  • Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
  • For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices

To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Total Total of all reporting groups

Baseline Measures
   Absorb BVS   XIENCE   Total 
Overall Participants Analyzed 
[Units: Participants]
 1322   686   2008 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.5  (10.6)   63.6  (10.3)   63.5  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      388  29.3%      205  29.9%      593  29.5% 
Male      934  70.7%      481  70.1%      1415  70.5% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   1322   686   2008 
Hypertension Requiring Medication 
[Units: Participants]
Count of Participants
 1071   553   1624 
Dyslipidemia Requiring Medication 
[Units: Participants]
Count of Participants
 1009   533   1542 
Prior Coronary Intervention 
[Units: Participants]
Count of Participants
 512   260   772 
Stable Angina 
[Units: Participants]
Count of Participants
 757   417   1174 


  Outcome Measures

1.  Primary:   Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)   [ Time Frame: 1 year ]

2.  Secondary:   Acute Success- Device Success (Lesion Level Analysis)   [ Time Frame: On day 0 (the day of procedure) ]

3.  Secondary:   Acute Success: Procedural Success (Subject Level Analysis)   [ Time Frame: On day 0 (the day of procedure) ]

4.  Secondary:   Number of Participants With Powered Secondary Endpoint: Angina   [ Time Frame: 1 year ]

5.  Secondary:   Number of Participants With Powered Secondary Endpoint: All Revascularization   [ Time Frame: 1 year ]

6.  Secondary:   Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 1 year ]

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

8.  Secondary:   Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 0 to 30 days ]

9.  Secondary:   Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 0 to 180 days ]

10.  Secondary:   Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 0 to 1 year ]

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

12.  Secondary:   Number of Participants With All Myocardial Infarction (MI)   [ Time Frame: 0 to 30 days ]

13.  Secondary:   Number of Participants With All Myocardial Infarction (MI)   [ Time Frame: 0 to 180 days ]

14.  Secondary:   Number of Participants With All Myocardial Infarction (MI)   [ Time Frame: 0 to 1 year ]

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

16.  Secondary:   Number of Participants With All Target Lesion Revascularization (TLR)   [ Time Frame: 0 to 30 days ]

17.  Secondary:   Number of Participants With All Target Lesion Revascularization (TLR)   [ Time Frame: 0 to 180 days ]

18.  Secondary:   Number of Participants With All Target Lesion Revascularization (TLR)   [ Time Frame: 0 to 1 year ]

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

20.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)   [ Time Frame: 0 to 30 days ]

21.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)   [ Time Frame: 0 to 180 days ]

22.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)   [ Time Frame: 0 to 1 year ]

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

24.  Secondary:   Number of Participants With All Revascularization   [ Time Frame: 0 to 30 days ]

25.  Secondary:   Number of Participants With All Revascularization   [ Time Frame: 0 to 180 days ]

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

27.  Secondary:   Number of Participants With Death/All MI   [ Time Frame: 0 to 30 days ]

28.  Secondary:   Number of Participants With Death/All MI   [ Time Frame: 0 to 180 days ]

29.  Secondary:   Number of Participants With Death/All MI   [ Time Frame: 0 to 1 year ]

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

31.  Secondary:   Number of Participants With Cardiac Death/All MI   [ Time Frame: 0 to 30 days ]

32.  Secondary:   Number of Participants With Cardiac Death/All MI   [ Time Frame: 0 to 180 days ]

33.  Secondary:   Number of Participants With Cardiac Death/All MI   [ Time Frame: 0 to 1 year ]

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

35.  Secondary:   Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)   [ Time Frame: 0 to 30 days ]

36.  Secondary:   Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)   [ Time Frame: 0 to 180 days ]

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

38.  Secondary:   Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)   [ Time Frame: 0 to 30 days ]

39.  Secondary:   Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)   [ Time Frame: 0 to 180 days ]

40.  Secondary:   Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)   [ Time Frame: 0 to 1 year ]

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

42.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 0 to 30 days ]

43.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 0 to 180 days ]

44.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 0 to 1 year ]

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

46.  Secondary:   Number of Participants With Death/All MI/All Revascularization (DMR)   [ Time Frame: 0 to 30 days ]

47.  Secondary:   Number of Participants With Death/All MI/All Revascularization (DMR)   [ Time Frame: 0 to 180 days ]

48.  Secondary:   Number of Participants With Death/All MI/All Revascularization (DMR)   [ Time Frame: 0 to 1 year ]

49.  Secondary:   Number of Participants With Acute Scaffold/Stent Thrombosis (Per ARC Definition)   [ Time Frame: ≤ 1 Day ]

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

51.  Secondary:   Number of Participants With Acute/Subacute Scaffold/Stent Thrombosis (Per ARC Definition)   [ Time Frame: 0 to 30 days ]

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

53.  Secondary:   Number of Participants With Very Late Scaffold/Stent Thrombosis (Per ARC Definition)   [ Time Frame: 366 to 393 Days ]

54.  Secondary:   Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition)   [ Time Frame: 0 to 393 Days ]

55.  Secondary:   Pre-Procedure Minimum Lumen Diameter (MLD)   [ Time Frame: < or = 1 day ]

56.  Secondary:   Pre-Procedure Percent Diameter Stenosis (%DS)   [ Time Frame: < or = 1 day ]

57.  Secondary:   Post-Procedure In-Segment Minimum Lumen Diameter (MLD)   [ Time Frame: ≤ 7 days post index procedure ]

58.  Secondary:   Post-Procedure In-Device Minimum Lumen Diameter (MLD)   [ Time Frame: ≤ 7 days post index procedure ]

59.  Secondary:   Post-Procedure In-Segment Percent Diameter Stenosis (%DS)   [ Time Frame: ≤ 7 days post index procedure ]

60.  Secondary:   Post-Procedure In-Device Percent Diameter Stenosis (%DS)   [ Time Frame: ≤ 7 days post index procedure ]

61.  Other Pre-specified:   Patient Reported Outcomes (PRO): Overall Health Status   [ Time Frame: Baseline ]

62.  Other Pre-specified:   Patient Reported Outcomes (PRO): Overall Health Status   [ Time Frame: 1 month ]

63.  Other Pre-specified:   Patient Reported Outcomes (PRO): Overall Health Status   [ Time Frame: 12 months ]

64.  Other Pre-specified:   Patient Reported Outcomes (PRO): Anxiety   [ Time Frame: Baseline ]

65.  Other Pre-specified:   Patient Reported Outcomes (PRO): Anxiety   [ Time Frame: 1 month ]

66.  Other Pre-specified:   Patient Reported Outcomes (PRO): Anxiety   [ Time Frame: 12 months ]

67.  Other Pre-specified:   Patient Reported Outcomes (PRO): Disease-Specific Quality of Life   [ Time Frame: Baseline ]

68.  Other Pre-specified:   Patient Reported Outcomes (PRO): Disease-Specific Quality of Life   [ Time Frame: 1 month ]

69.  Other Pre-specified:   Patient Reported Outcomes (PRO): Disease-Specific Quality of Life   [ Time Frame: 12 months ]

70.  Other Pre-specified:   Patient Reported Outcomes (PRO): Dyspnea Severity   [ Time Frame: Baseline ]

71.  Other Pre-specified:   Patient Reported Outcomes (PRO): Dyspnea Severity   [ Time Frame: 1 month ]

72.  Other Pre-specified:   Patient Reported Outcomes (PRO): Dyspnea Severity   [ Time Frame: 12 months ]

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

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

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

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

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

78.  Secondary:   Number of Participants With All Myocardial Infarction (MI)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

79.  Secondary:   Number of Participants With All Myocardial Infarction (MI)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

80.  Secondary:   Number of Participants With All Myocardial Infarction (MI)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

81.  Secondary:   Number of Participants With All Target Lesion Revascularization (TLR)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

82.  Secondary:   Number of Participants With All Target Lesion Revascularization (TLR)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

83.  Secondary:   Number of Participants With All Target Lesion Revascularization (TLR)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

84.  Secondary:   Number of Participants With All Target Lesion Revascularization (TLR)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

85.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

86.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

87.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

88.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

89.  Secondary:   Number of Participants With All Revascularization   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

90.  Secondary:   Number of Participants With All Revascularization   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

91.  Secondary:   Number of Participants With All Revascularization   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

92.  Secondary:   Number of Participants With All Revascularization   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

93.  Secondary:   Number of Participants With Death/All MI   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

94.  Secondary:   Number of Participants With Death/All MI   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

95.  Secondary:   Number of Participants With Death/All MI   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

96.  Secondary:   Number of Participants With Death/All MI   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

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

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

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

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

101.  Secondary:   Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

102.  Secondary:   Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

103.  Secondary:   Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

104.  Secondary:   Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

105.  Secondary:   Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

106.  Secondary:   Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

107.  Secondary:   Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

108.  Secondary:   Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

109.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

110.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

111.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

112.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

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

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

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

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

117.  Secondary:   Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

118.  Secondary:   Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

119.  Secondary:   Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

120.  Secondary:   Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

121.  Secondary:   Landmark Analysis on TLF and Components   [ Time Frame: 1-3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

122.  Secondary:   Landmark Analysis on TLF and Components   [ Time Frame: 1-4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

123.  Secondary:   Landmark Analysis on TLF and Components   [ Time Frame: 1-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

124.  Secondary:   Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)   [ Time Frame: 1-3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

125.  Secondary:   Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)   [ Time Frame: 1-4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

126.  Secondary:   Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)   [ Time Frame: 1-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

127.  Secondary:   Powered Imaging Cohort Secondary Endpoint: The In-stent/Scaffold Mean Lumen Diameter Change, Between Pre- and Post-nitrate Infusion at 3 Years by Angiography   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

128.  Secondary:   Powered Imaging Cohort Secondary Endpoint: The In-stent/Scaffold Mean Lumen Area Change, From Post-procedure to 3 Years by Intravascular Ultrasound (IVUS)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

129.  Secondary:   Optical Coherence Tomography (OCT) Endpoint   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

130.  Other Pre-specified:   Patient Reported Outcomes (PRO)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

131.  Other Pre-specified:   Patient Reported Outcomes (PRO)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

132.  Other Pre-specified:   Patient Reported Outcomes (PRO)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

133.  Other Pre-specified:   Patient Reported Outcomes (PRO)   [ 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: Dana Haudek / Project Manager
Organization: Abbott Vascular
phone: 928-925-4054
e-mail: dana.haudek@abbott.com


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


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01751906     History of Changes
Other Study ID Numbers: 10-392
First Submitted: December 13, 2012
First Posted: December 18, 2012
Results First Submitted: August 29, 2017
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018