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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
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
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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 1800 subjects were enrolled at 87 outside US (OUS) study sites across 21 counties worldwide. The first patient registered on January 21, 2013. The patient registration was complete on Aug 30, 2014, and the last patient completed the 1-year clinical follow-up on Sep 09, 2015. The database has been closed on Oct 30, 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 81 subjects are discontinued from the study population (1800) due to death:17, withdrawal of consent:5, withdrawn by physician:2, loss to follow-up:53 and unknown reasons:4. A total of 28 subjects with MI/revascularization events or reached 1-year follow-up window were included in the clinical outcome analysis.

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

Participant Flow:   Overall Study
    Absorb Bioresorbable Vascular Scaffold
STARTED   1800 
COMPLETED   1719 
NOT COMPLETED   81 
Subjects withdrawn consent                5 
Physician Decision                2 
Death                17 
Lost to Follow-up                53 
Unknown reason                4 



  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.
No text entered.

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 ]

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

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 ]

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

5.  Secondary:   Subacute ScaffoldThrombosis   [ Time Frame: 1 to 30 days ]

6.  Secondary:   Late Scaffold Thrombosis   [ Time Frame: 31 to 365 Days ]

7.  Secondary:   All Death, All MI, All Revascularization (DMR)   [ Time Frame: 0 to 7 days (In-hospital) ]

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

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

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

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

12.  Secondary:   All Death/All MI   [ Time Frame: 0 to 7 days (In-hospital) ]

13.  Secondary:   All Death, All MI, All Revascularization (DMR)   [ Time Frame: 0 to 37 days ]

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

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

16.  Secondary:   Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))   [ Time Frame: 0 to 37 Days ]

17.  Secondary:   Cardiac Death/All MI   [ Time Frame: 0 to 37 days ]

18.  Secondary:   All Death/All MI   [ Time Frame: 0 to 37 days ]

19.  Secondary:   All Death, All MI, All Revascularization (DMR)   [ Time Frame: 0 to 180 days ]

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

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

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

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

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

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

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

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

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

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

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

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) ]

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

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

34.  Secondary:   Target Vessel Revascularization (TVR): All TVR   [ Time Frame: 0 to 7 days (In-hospital) ]

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

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

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

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 ]

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

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

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

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

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

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

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 ]

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

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

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

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

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

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

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 ]

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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