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The INFUSE - Anterior Myocardial Infarction (AMI) Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Atrium Medical Corporation
ClinicalTrials.gov Identifier:
NCT00976521
First received: September 11, 2009
Last updated: May 31, 2013
Last verified: May 2013
Results First Received: April 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Acute Anterior Myocardial Infarction
Interventions: Drug: Abciximab local infusion
Other: No local infusion
Procedure: Thrombus aspiration

  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
Between 28-Nov-09 and 02-Dec-11, 452 subjects meeting all clinical eligibility criteria were consented and enrolled at 37 US and European sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized in a 1:1:1:1 ratio to each of the randomized groups (abciximab infusion with aspiration, abciximab infusion without aspiration, no infusion with aspiration, no infusion without aspiration).

Reporting Groups
  Description
Local Infusion, Thrombus Aspiration

Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.

A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed.

After withdrawing the aspiration catheter, the lesion is crossed with a 1.0 mm, 1.5 mm, or 2.0 mm diameter ClearWay™ RX Infusion Catheter (depending on the lumen diameter created by thrombus aspiration and the reference vessel diameter). If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter.

Local Infusion, no Aspiration

Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.

The initial device used to cross the lesion is a 1.0 mm or 1.5 mm diameter ClearWay™ RX Infusion Catheter (1.0 mm for complete occlusion).

If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter.

No Local Infusion, Thrombus Aspiration

No local infusion of abciximab, thrombus aspiration.

A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed.

No Local Infusion, no Aspiration

No local infusion of abciximab and no thrombus aspiration.

The lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.


Participant Flow:   Overall Study
    Local Infusion, Thrombus Aspiration   Local Infusion, no Aspiration   No Local Infusion, Thrombus Aspiration   No Local Infusion, no Aspiration
STARTED   118   111   111   112 
COMPLETED   109   99   102   93 
NOT COMPLETED   9   12   9   19 



  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
Local Infusion, Thrombus Aspiration Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
Local Infusion, no Aspiration Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration
No Local Infusion, Thrombus Aspiration No local infusion of abciximab, thrombus aspiration.
No Local Infusion, no Aspiration No local infusion of abciximab and no thrombus aspiration
Total Total of all reporting groups

Baseline Measures
   Local Infusion, Thrombus Aspiration   Local Infusion, no Aspiration   No Local Infusion, Thrombus Aspiration   No Local Infusion, no Aspiration   Total 
Overall Participants Analyzed 
[Units: Participants]
 118   111   111   112   452 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   80   79   61   67   287 
>=65 years   38   32   50   45   165 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 60.0 
 (52.0 to 66.0) 
 56.0 
 (49.0 to 68.0) 
 62.0 
 (53.0 to 73.0) 
 62.5 
 (52.5 to 71.0) 
 61.0 
 (52.0 to 72.0) 
Gender 
[Units: Participants]
         
Female   34   27   26   31   118 
Male   84   84   85   81   334 
Region of Enrollment 
[Units: Participants]
         
United States   14   15   12   12   53 
Poland   25   24   27   23   99 
Austria   13   14   11   9   47 
Netherlands   14   11   10   15   50 
Germany   22   21   19   19   81 
United Kingdom   30   26   32   34   122 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion   [ Time Frame: 30 Days Post Index Procedure ]

2.  Secondary:   Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration   [ Time Frame: 30 Days ]


  Serious Adverse Events


  Other Adverse Events


  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 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.


Results Point of Contact:  
Name/Title: Leah Hollins, Director of Clinical Affairs
Organization: Atrium Medical Corporation
phone: 603-880-1433 ext 5365
e-mail: lhollins@atriummed.com


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


Responsible Party: Atrium Medical Corporation
ClinicalTrials.gov Identifier: NCT00976521     History of Changes
Other Study ID Numbers: 901
Study First Received: September 11, 2009
Results First Received: April 12, 2013
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration