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ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01759290
First received: December 14, 2012
Last updated: August 26, 2016
Last verified: August 2016
History of Changes
Results First Received: August 26, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Chronic Total Occlusion of Coronary Artery
Coronary Occlusion
Coronary Artery Disease
Coronary Artery Restenosis
Coronary Artery Stenosis
Coronary Disease
Coronary Restenosis
Intervention: Device: Absorb Bioresorbable Vascular Scaffold

  Participant Flow
  Show Participant Flow


  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.
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Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Baseline Measures
   Absorb Bioresorbable Vascular Scaffold 
Overall Participants Analyzed 
[Units: Participants]
 		 1800 
Age 
[Units: Years]
Mean (Standard Deviation) 		 58.8  (11) 
Gender 
[Units: Participants]
 		 
Female   362 
Male   1438 
Region of Enrollment 
[Units: Participants]
 		 
Germany   378 
Spain   308 
Netherlands   144 
Belgium   119 
Singapore   93 
Malaysia   88 
Thailand   75 
Colombia   74 
United Arab Emirates   65 
Indonesia   64 
France   59 
Switzerland   59 
Austria   51 
New Zealand   42 
Saudi Arabia   39 
Jordan   37 
Bahrain   33 
Vietnam   33 
Poland   22 
Italy   12 
Philippines   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 1

2.  Secondary:   Acute Success: Clinical Device Success (Lesion Level Analysis)   [ Time Frame: < or = 1 day ]
  Show Outcome Measure 2

3.  Secondary:   Acute Success: Clinical Procedure Success (Per Subject Analysis)   [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure ]
  Show Outcome Measure 3

4.  Secondary:   Acute Scaffold Thrombosis   [ Time Frame: <1 day ]
  Show Outcome Measure 4

5.  Secondary:   Subacute ScaffoldThrombosis   [ Time Frame: 1 to 30 days ]
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6.  Secondary:   Late Scaffold Thrombosis   [ Time Frame: 31 to 365 Days ]
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7.  Secondary:   All Death, All MI, All Revascularization (DMR)   [ Time Frame: 0 to 7 days (In-hospital) ]
  Show Outcome Measure 7

8.  Secondary:   Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)   [ Time Frame: 0 to 7 days (In-hospital) ]
  Show Outcome Measure 8

9.  Secondary:   Major Adverse Cardiac Event (MACE)   [ Time Frame: 0 to 7 days (In-hospital) ]
  Show Outcome Measure 9

10.  Secondary:   Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))   [ Time Frame: 0 to 7 days (In-hospital) ]
  Show Outcome Measure 10

11.  Secondary:   Cardiac Death/All MI   [ Time Frame: 0 to 7 days (In-hospital) ]
  Show Outcome Measure 11

12.  Secondary:   All Death/All MI   [ Time Frame: 0 to 7 days (In-hospital) ]
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13.  Secondary:   All Death, All MI, All Revascularization (DMR)   [ Time Frame: 0 to 37 days ]
  Show Outcome Measure 13

14.  Secondary:   Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)   [ Time Frame: 0 to 37 days ]
  Show Outcome Measure 14

15.  Secondary:   Major Adverse Cardiac Event (MACE)   [ Time Frame: 0 - 37 Days ]
  Show Outcome Measure 15

16.  Secondary:   Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))   [ Time Frame: 0 to 37 Days ]
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17.  Secondary:   Cardiac Death/All MI   [ Time Frame: 0 to 37 days ]
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18.  Secondary:   All Death/All MI   [ Time Frame: 0 to 37 days ]
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19.  Secondary:   All Death, All MI, All Revascularization (DMR)   [ Time Frame: 0 to 180 days ]
  Show Outcome Measure 19

20.  Secondary:   Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)   [ Time Frame: 0 to 180 days ]
  Show Outcome Measure 20

21.  Secondary:   Major Adverse Cardiac Event (MACE)   [ Time Frame: 0 to 180 Days ]
  Show Outcome Measure 21

22.  Secondary:   Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))   [ Time Frame: 0 to 180 Days ]
  Show Outcome Measure 22

23.  Secondary:   Cardiac Death/All MI   [ Time Frame: 0 to 180 days ]
  Show Outcome Measure 23

24.  Secondary:   All Death/All MI   [ Time Frame: 0 to 180 days ]
  Show Outcome Measure 24

25.  Secondary:   All Death, All MI, All Revascularization (DMR)   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 25

26.  Secondary:   Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 26

27.  Secondary:   Major Adverse Cardiac Event (MACE)   [ Time Frame: 0 to 407 Days ]
  Show Outcome Measure 27

28.  Secondary:   Cardiac Death/All MI   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 28

29.  Secondary:   All Death/All MI   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 29

30.  Secondary:   Death (Cardiovascular, Non-Cardiovascular)   [ Time Frame: 0 to 7 days (In-hospital) ]
  Show Outcome Measure 30

31.  Secondary:   All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).   [ Time Frame: 0 to 7 days (In-hospital) ]
  Show Outcome Measure 31

32.  Secondary:   Target Lesion Revascularization (TLR): All TLR   [ Time Frame: 0 to 7 days (In-hospital) ]
  Show Outcome Measure 32

33.  Secondary:   Target Lesion Revascularization : Ischemia-Driven (ID-TLR)   [ Time Frame: 0 to 7 days (In-hospital) ]
  Show Outcome Measure 33

34.  Secondary:   Target Vessel Revascularization (TVR): All TVR   [ Time Frame: 0 to 7 days (In-hospital) ]
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35.  Secondary:   Target Vessel Revascularization : Ischemic-driven (ID-TVR)   [ Time Frame: 0 to 7 days (In-hospital) ]
  Show Outcome Measure 35

36.  Secondary:   All Revascularization   [ Time Frame: 0 to 7 days (In-hospital) ]
  Show Outcome Measure 36

37.  Secondary:   Death (Cardiovascular, Non-Cardiovascular)   [ Time Frame: 0 to 37 days ]
  Show Outcome Measure 37

38.  Secondary:   All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).   [ Time Frame: 0 to 37 days ]
  Show Outcome Measure 38

39.  Secondary:   Target Lesion Revascularization (TLR): All TLR   [ Time Frame: 0 to 37 days ]
  Show Outcome Measure 39

40.  Secondary:   Target Lesion Revascularization : Ischemia-Driven (ID-TLR)   [ Time Frame: 0 to 37 days ]
  Show Outcome Measure 40

41.  Secondary:   Target Vessel Revascularization (TVR): All TVR   [ Time Frame: 0 to 37 days ]
  Show Outcome Measure 41

42.  Secondary:   Target Vessel Revascularization : Ischemic-driven (ID-TVR)   [ Time Frame: 0 to 37 days ]
  Show Outcome Measure 42

43.  Secondary:   All Revascularization   [ Time Frame: 0 to 37 days ]
  Show Outcome Measure 43

44.  Secondary:   Death (Cardiovascular, Non-Cardiovascular)   [ Time Frame: 0 to 180 days ]
  Show Outcome Measure 44

45.  Secondary:   All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).   [ Time Frame: 0 to 180 days ]
  Show Outcome Measure 45

46.  Secondary:   Target Lesion Revascularization (TLR): All TLR   [ Time Frame: 0 to 180 days ]
  Show Outcome Measure 46

47.  Secondary:   Target Lesion Revascularization : Ischemia-Driven (ID-TLR)   [ Time Frame: 0 to 180 days ]
  Show Outcome Measure 47

48.  Secondary:   Target Vessel Revascularization (TVR): All TVR   [ Time Frame: 0 to 180 days ]
  Show Outcome Measure 48

49.  Secondary:   Target Vessel Revascularization : Ischemic-driven (ID-TVR)   [ Time Frame: 0 to 180 days ]
  Show Outcome Measure 49

50.  Secondary:   All Revascularization   [ Time Frame: 0 to 180 days ]
  Show Outcome Measure 50

51.  Secondary:   Death (Cardiovascular, Non-Cardiovascular)   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 51

52.  Secondary:   All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 52

53.  Secondary:   Target Lesion Revascularization (TLR): All TLR   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 53

54.  Secondary:   Target Lesion Revascularization : Ischemia-Driven (ID-TLR)   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 54

55.  Secondary:   Target Vessel Revascularization (TVR): All TVR   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 55

56.  Secondary:   Target Vessel Revascularization : Ischemic-driven (ID-TVR)   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 56

57.  Secondary:   All Revascularization   [ Time Frame: 0 to 407 days ]
  Show Outcome Measure 57


  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 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 less than or equal to 60 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: Kunal Sampat
Organization: Abbott Vascular
phone: 408-845-0746
e-mail: kunal.sampat@av.abbott.com



Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01759290     History of Changes
Other Study ID Numbers: 12-302
Study First Received: December 14, 2012
Results First Received: August 26, 2016
Last Updated: August 26, 2016