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ABSORB EXTEND Clinical Investigation (ABSORB EXTEND)

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ClinicalTrials.gov Identifier: NCT01023789
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : December 18, 2017
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Cardiovascular Disease
Intervention: Device: ABSORB BVS

  Participant Flow

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 812 subjects (Intent-to-treat population) have been registered in 25 countries across the globe in compliance with the study Clinical Investigation Plan (CIP).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of the 812 subjects registered, a total of 43 subjects discontinued the study due to death (n=29) , withdrawal of consent (n=1) and lost-to-follow-up or missed the final 3 year follow-up visit (n=13).

Reporting Groups
  Description
ABSORB BVS Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease

Participant Flow for 5 periods

Period 1:   30-day Follow-up Visit
    ABSORB BVS
STARTED   812 [1] 
COMPLETED   812 
NOT COMPLETED   0 
[1] Intent-to-treat population (ITT).

Period 2:   180-day Clinical Follow-up
    ABSORB BVS
STARTED   812 
COMPLETED   812 
NOT COMPLETED   0 

Period 3:   1 - Year Visit
    ABSORB BVS
STARTED   812 
COMPLETED   812 
NOT COMPLETED   0 

Period 4:   2 - Year Visit
    ABSORB BVS
STARTED   812 
COMPLETED   812 
NOT COMPLETED   0 

Period 5:   3 - Year Visit
    ABSORB BVS
STARTED   812 
COMPLETED   769 
NOT COMPLETED   43 
Death                29 
Withdrawal of consent                1 
Lost to Follow-up                13 



  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 Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease

Baseline Measures
   ABSORB BVS 
Overall Participants Analyzed 
[Units: Participants]
 812 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.12  (10.75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      209  25.7% 
Male      603  74.3% 
Region of Enrollment 
[Units: Participants]
 
Singapore   20 
Malaysia   23 
Austria   24 
Netherlands   67 
Sweden   3 
Hong Kong   21 
Brazil   97 
Poland   13 
France   57 
Argentina   20 
Japan   40 
United Kingdom   12 
Switzerland   13 
India   100 
Spain   13 
New Zealand   23 
Canada   27 
Belgium   21 
Taiwan   74 
Denmark   15 
Italy   21 
South Africa   4 
Israel   13 
Australia   62 
Germany   29 


  Outcome Measures

1.  Primary:   Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)   [ Time Frame: ≤ 7 days post index procedure (In hospital) ]

2.  Primary:   Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)   [ Time Frame: 0 to 30 days ]

3.  Primary:   Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)   [ Time Frame: 0 to 180 days ]

4.  Primary:   Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)   [ Time Frame: 0 to 1 year ]

5.  Secondary:   Clinical Device Success   [ Time Frame: On day 0 (immediate post-index procedure) ]

6.  Secondary:   Clinical Procedure Success   [ Time Frame: On day 0 (immediate post-index procedure) ]

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

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

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

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

11.  Secondary:   Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)   [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

12.  Secondary:   Number of Participants With Cardiac Death   [ Time Frame: 0 to 30 days ]

13.  Secondary:   Number of Participants With Myocardial Infarction (MI) - Per Protocol   [ Time Frame: 0 to 30 days ]

14.  Secondary:   Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 0 to 30 days ]

15.  Secondary:   Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 0 to 30 days ]

16.  Secondary:   Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)   [ Time Frame: 0 to 30 days ]

17.  Secondary:   Number of Participants With Cardiac Death   [ Time Frame: 0 to 180 days ]

18.  Secondary:   Number of Participants With Myocardial Infarction (MI) - Per Protocol   [ Time Frame: 0 to 180 days ]

19.  Secondary:   Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 0 to 180 days ]

20.  Secondary:   Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 0 to 180 days ]

21.  Secondary:   Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)   [ Time Frame: 0 to 180 days ]

22.  Secondary:   Number of Participants With Cardiac Death   [ Time Frame: 0 to 1 year ]

23.  Secondary:   Number of Participants With Myocardial Infarction (MI) - Per Protocol   [ Time Frame: 0 to 1 year ]

24.  Secondary:   Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 0 to 1 year ]

25.  Secondary:   Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 0 to 1 year ]

26.  Secondary:   Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)   [ Time Frame: 0 to 1 year ]

27.  Secondary:   Number of Participants With Cardiac Death   [ Time Frame: 0 to 2 year ]

28.  Secondary:   Number of Participants With Myocardial Infarction (MI) - Per Protocol   [ Time Frame: 0 to 2 year ]

29.  Secondary:   Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 0 to 2 year ]

30.  Secondary:   Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 0 to 2 year ]

31.  Secondary:   Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)   [ Time Frame: 0 to 2 year ]

32.  Secondary:   Number of Participants With Cardiac Death   [ Time Frame: 0 to 3 years ]

33.  Secondary:   Number of Participants With Myocardial Infarction (MI) - Per Protocol   [ Time Frame: 0 to 3 years ]

34.  Secondary:   Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 0 to 3 years ]

35.  Secondary:   Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 0 to 3 years ]

36.  Secondary:   Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)   [ Time Frame: 0 to 3 years ]

37.  Secondary:   Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)   [ Time Frame: ≤ 7 days post index procedure (In hospital) ]

38.  Secondary:   Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)   [ Time Frame: 0 to 30 days ]

39.  Secondary:   Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)   [ Time Frame: 0 to 180 days ]

40.  Secondary:   Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)   [ Time Frame: 0 to 1 year ]

41.  Secondary:   Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)   [ Time Frame: 0 to 2 years ]

42.  Secondary:   Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)   [ Time Frame: 0 to 3 years ]

43.  Secondary:   Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)   [ Time Frame: 0 to 2 years ]

44.  Secondary:   Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)   [ Time Frame: 0 to 3 years ]

45.  Secondary:   Number of Participants With Scaffold Thrombosis (Early)   [ Time Frame: 0 to 30 days ]

46.  Secondary:   Number of Participants With Scaffold Thrombosis   [ Time Frame: 0 to 180 days ]

47.  Secondary:   Number of Participants With Scaffold Thrombosis (Late)   [ Time Frame: 31 - 365 days ]

48.  Secondary:   Number of Participants With Scaffold Thrombosis   [ Time Frame: 0 to 1 year ]

49.  Secondary:   Number of Participants With Scaffold Thrombosis (Very Late)   [ Time Frame: 366 days to 2 years ]

50.  Secondary:   Number of Participants With Scaffold Thrombosis   [ Time Frame: 0 to 2 years ]

51.  Secondary:   Number of Participants With Scaffold Thrombosis   [ Time Frame: 0 to 3 years ]

52.  Secondary:   Area Stenosis (%)   [ Time Frame: 18 months ]

53.  Secondary:   Minimum Lumen Area   [ Time Frame: 18 months ]

54.  Secondary:   Mean Vessel Area   [ Time Frame: 18 months ]

55.  Secondary:   Minimum Vessel Area   [ Time Frame: 18 months ]

56.  Secondary:   Maximum Vessel Area   [ Time Frame: 18 months ]

57.  Secondary:   Mean Lumen Area   [ Time Frame: 18 months ]

58.  Secondary:   Maximum Lumen Area   [ Time Frame: 18 months ]

59.  Secondary:   Mean Plaque Area   [ Time Frame: 18 months ]

60.  Secondary:   Minimum Plaque Area   [ Time Frame: 18 months ]

61.  Secondary:   Maximum Plaque Area   [ Time Frame: 18 months ]

62.  Secondary:   Mean Reference Area   [ Time Frame: 18 months ]

63.  Secondary:   Calculated Minimum Lumen Diameter   [ Time Frame: 18 months ]

64.  Secondary:   Calculated Diameter Stenosis   [ Time Frame: 18 months ]


  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: Susan Veldhof
Organization: Abbott Vascular International BVBA
phone: +31653428610
e-mail: susan.veldhof@av.abbott.com


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


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01023789     History of Changes
Other Study ID Numbers: 09-386
ACTRN12610000131055 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
REFCTRI000460, 03-05-2010 ( Registry Identifier: Clinical Trials Registry - India )
First Submitted: November 30, 2009
First Posted: December 2, 2009
Results First Submitted: May 18, 2017
Results First Posted: December 18, 2017
Last Update Posted: February 14, 2018