Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01794949
Recruitment Status : Completed
First Posted : February 20, 2013
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Henry A Liberman, Emory University

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
Enrollment 8
Recruitment Details 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 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.
Arm/Group Title Non-diabetic Patients Receiving the Resolute Stent NIDDM Patients Receiving the Resolute Stent
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 7 1
6 Month Follow-up 6 1
Completed 6 1
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Non-diabetic Patients Receiving the Resolute Stent NIDDM Patients Receiving the Resolute Stent Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 7 1 8
Hide Baseline Analysis Population Description
Individuals who consented to participate in the study and met all eligibility criteria.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 1 participants 8 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 1 participants 8 participants
Female
1
  14.3%
1
 100.0%
2
  25.0%
Male
6
  85.7%
0
   0.0%
6
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 1 participants 8 participants
7 1 8
1.Primary Outcome
Title Percent Stent Coverage
Hide Description Assessment of vascular healing 6 months after Resolute Integrity placement in non-diabetic patients and patients with non-insulin dependent diabetes presenting with acute coronary syndrome (ACS) using optical frequency domain imaging (OFDI). Vascular healing will be measured by percent covered stents as determined by OFDI. A higher percentage of stent coverage indicates increased endothelial regrowth, which is an essential component for the maintenance of long-term luminal patency.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants included in the analyses for this outcome are those who completed the 6 month follow-up imaging to assess vascular healing. Optical frequency domain imaging (OFDI) was not performed on two participants in the non-diabetic study arm.
Arm/Group Title Non-diabetic Patients Receiving the Resolute Stent NIDDM Patients Receiving the Resolute Stent
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 5 1
Measure Type: Count of Participants
Unit of Measure: Participants
85% up to 90% stent coverage
1
  20.0%
0
   0.0%
90% up to 95% stent coverage
3
  60.0%
1
 100.0%
95% or greater percent stent coverage
1
  20.0%
0
   0.0%
Time Frame Participants were followed for adverse events for 6 months after having the study procedure. Adverse events were followed until the event subsided or, in the case of permanent impairment, the event stabilized and the overall clinical outcome was ascertained.
Adverse Event Reporting Description Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
 
Arm/Group Title Non-diabetic Patients Receiving the Resolute Stent NIDDM Patients Receiving the Resolute Stent
Hide Arm/Group Description 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 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
All-Cause Mortality
Non-diabetic Patients Receiving the Resolute Stent NIDDM Patients Receiving the Resolute Stent
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/1 (0.00%)    
Hide Serious Adverse Events
Non-diabetic Patients Receiving the Resolute Stent NIDDM Patients Receiving the Resolute Stent
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/7 (42.86%)      0/1 (0.00%)    
Cardiac disorders     
Heart attack symptoms * [1]  1/7 (14.29%)  1 0/1 (0.00%)  0
Presyncope *  1/7 (14.29%)  1 0/1 (0.00%)  0
Vascular disorders     
Coronary occlusion *  1/7 (14.29%)  1 0/1 (0.00%)  0
Iliac occlusion *  1/7 (14.29%)  1 0/1 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Lethargy, back pain, chest pain, panic attack resulted in a repeat angiogram. The Left Anterior Descending (LAD) artery sent was patent and the symptoms resolved without treatment.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-diabetic Patients Receiving the Resolute Stent NIDDM Patients Receiving the Resolute Stent
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/7 (28.57%)      0/1 (0.00%)    
Cardiac disorders     
Chest pain *  1/7 (14.29%)  1 0/1 (0.00%)  0
Renal and urinary disorders     
Elevated creatinine *  1/7 (14.29%)  1 0/1 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Henry Liberman, MD
Organization: Emory University
Phone: 404-686-2503
EMail: hliberm@emory.edu
Layout table for additonal information
Responsible Party: Henry A Liberman, Emory University
ClinicalTrials.gov Identifier: NCT01794949    
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