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  
Number of Participants  
[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


No publications provided by Atrium Medical Corporation

Publications automatically indexed to this study:


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