DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting

This study has been completed.
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01297257
First received: December 20, 2010
Last updated: January 21, 2014
Last verified: January 2014
Results First Received: November 20, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Coronary Artery Disease
Intervention: Device: Stent implantation

  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
Patients were enrolled at 163 centres in Europe, Asia, the Middle East, and Latin America from January 2011 to May 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

7845 subjects enrolled in this study. 22 Subjects removed from database, per center request. Reasons varied per center.

83 patients had very limited data available which resulted in the inability to be included in the analysis.


Reporting Groups
  Description
Group 1 Resolute Integrity™ Stent Primary Stent A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.

Participant Flow:   Overall Study
    Group 1 Resolute Integrity™ Stent Primary Stent  
STARTED     7740  
COMPLETED     7740  
NOT COMPLETED     0  



  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
Group 1 Resolute Integrity™ Stent Primary Stent A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.

Baseline Measures
    Group 1 Resolute Integrity™ Stent Primary Stent  
Number of Participants  
[units: participants]
  7740  
Age [1]
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4058  
>=65 years     3662  
Age [2]
[units: years]
Mean ± Standard Deviation
  63.5  ± 11.2  
Gender [3]
[units: participants]
 
Female     1858  
Male     5862  
[1] Age of 20 (0.26%) patients not reported by investigators.
[2] Age of 20 (0.26%) patients not reported by investigators
[3] Gender of 20 (0.26%) patients not reported by investigators



  Outcome Measures
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1.  Primary:   Delivery Success   [ Time Frame: stent implantation until hospital discharge (average 1-3 days) ]

2.  Secondary:   In-hospital MACE (Major Adverse Cardiac Event)   [ Time Frame: stent implantation until hospital discharge (average 1-3 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: Frank van Leeuwen, M.D.
Organization: Clinical Research Director
phone: +31433566622
e-mail: frank.van.leeuwen@medtronic.com


No publications provided


Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01297257     History of Changes
Other Study ID Numbers: IP992
Study First Received: December 20, 2010
Results First Received: November 20, 2013
Last Updated: January 21, 2014
Health Authority: Italy: Ministry of Health
Israel: Ministry of Health