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Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement (OFDI-DM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01794949
First Posted: February 20, 2013
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Henry A Liberman, Emory University
Results First Submitted: April 6, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Participants were selected from patients with acute coronary syndrome (ACS) presenting to Emory University Hospital Midtown for coronary angiography. Participants were recruited between September 2013 and September 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 24 individuals who signed the consent form, 16 were found to be ineligible to participate in the study, resulting in 8 participants who started the trial.

Reporting Groups
  Description
Non-diabetic Patients Receiving the Resolute Stent Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
NIDDM Patients Receiving the Resolute Stent Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent

Participant Flow:   Overall Study
    Non-diabetic Patients Receiving the Resolute Stent   NIDDM Patients Receiving the Resolute Stent
STARTED   7   1 
6 Month Follow-up   6   1 
COMPLETED   6   1 
NOT COMPLETED   1   0 
Lost to Follow-up                1                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.
Individuals who consented to participate in the study and met all eligibility criteria.

Reporting Groups
  Description
Non-diabetic Patients Receiving the Resolute Stent Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
NIDDM Patients Receiving the Resolute Stent Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
Total Total of all reporting groups

Baseline Measures
   Non-diabetic Patients Receiving the Resolute Stent   NIDDM Patients Receiving the Resolute Stent   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   1   8 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5  71.4%      0   0.0%      5  62.5% 
>=65 years      2  28.6%      1 100.0%      3  37.5% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  14.3%      1 100.0%      2  25.0% 
Male      6  85.7%      0   0.0%      6  75.0% 
Region of Enrollment 
[Units: Participants]
     
United States   7   1   8 


  Outcome Measures

1.  Primary:   Percent Stent Coverage   [ Time Frame: 6 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
Due to low enrollment there were not enough participants to provide 80% power for the comparison between the study arms, therefore, statistical analyses were not performed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Henry Liberman, MD
Organization: Emory University
phone: 404-686-2503
e-mail: hliberm@emory.edu


Publications:

Responsible Party: Henry A Liberman, Emory University
ClinicalTrials.gov Identifier: NCT01794949     History of Changes
Other Study ID Numbers: IRB00057208
First Submitted: November 7, 2012
First Posted: February 20, 2013
Results First Submitted: April 6, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017