An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (RI-US)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01638507
First received: July 9, 2012
Last updated: October 23, 2015
Last verified: October 2015
Results First Received: October 23, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Device: Resolute Integrity Stent

  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
230 PEG subjects were enrolled from 29 study sites in the United States. The first subject was enrolled on July 23, 2012 and the last subject was enrolled on May 31, 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Primary Enrollment Group (PEG) Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.

Participant Flow:   Overall Study
    Primary Enrollment Group (PEG)  
STARTED     230  
COMPLETED     224  
NOT COMPLETED     6  



  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
Primary Enrollment Group (PEG) Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.

Baseline Measures
    Primary Enrollment Group (PEG)  
Number of Participants  
[units: participants]
  230  
Age  
[units: years]
Mean (Standard Deviation)
  64.4  (10.5)  
Gender  
[units: participants]
 
Female     70  
Male     160  



  Outcome Measures
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1.  Primary:   Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)   [ Time Frame: 12 months ]

2.  Secondary:   Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI   [ Time Frame: 12 months ]

3.  Secondary:   Clinical Endpoint: Death   [ Time Frame: 12 months ]

4.  Secondary:   Dual Antiplatelet Therapy (DAPT) Compliance   [ Time Frame: 12 months ]

5.  Secondary:   Clinical Endpoint: TLR   [ Time Frame: 12 months ]

6.  Secondary:   Clinical Endpoint: TVR   [ Time Frame: 12 months ]

7.  Secondary:   Clinical Endpoint: MI   [ Time Frame: 12 months ]

8.  Secondary:   Clinical Endpoint: ST   [ Time Frame: 12 months ]

9.  Secondary:   Clinical Endpoint: Stroke   [ Time Frame: 12 months ]

10.  Secondary:   Clinical Endpoint: Bleeding Complications in General   [ Time Frame: 12 months ]


  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: Lisa Bousquette, Clinical Research Director
Organization: Medtronic, Coronary Clinical Affairs
phone: (707) 591-2967
e-mail: lisa.r.bousquette@medtronic.com



Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01638507     History of Changes
Other Study ID Numbers: IP 126
Study First Received: July 9, 2012
Results First Received: October 23, 2015
Last Updated: October 23, 2015
Health Authority: United States: Institutional Review Board