Trial Outcomes & Findings for Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement (NCT NCT01794949)
NCT ID: NCT01794949
Last Updated: 2017-05-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
6 months
Results posted on
2017-05-15
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
1
|
|
Overall Study
6 Month Follow-up
|
6
|
1
|
|
Overall Study
COMPLETED
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement
Baseline characteristics by cohort
| Measure |
Non-diabetic Patients Receiving the Resolute Stent
n=7 Participants
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
n=1 Participants
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
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Non-diabetic Patients Receiving the Resolute Stent
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Percent Stent Coverage
85% up to 90% stent coverage
|
1 Participants
|
0 Participants
|
|
Percent Stent Coverage
90% up to 95% stent coverage
|
3 Participants
|
1 Participants
|
|
Percent Stent Coverage
95% or greater percent stent coverage
|
1 Participants
|
0 Participants
|
Adverse Events
Non-diabetic Patients Receiving the Resolute Stent
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
NIDDM Patients Receiving the Resolute Stent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-diabetic Patients Receiving the Resolute Stent
n=7 participants at risk
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
n=1 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Heart attack symptoms
|
14.3%
1/7 • Number of events 1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
0.00%
0/1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
|
Vascular disorders
Coronary occlusion
|
14.3%
1/7 • Number of events 1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
0.00%
0/1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
|
Cardiac disorders
Presyncope
|
14.3%
1/7 • Number of events 1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
0.00%
0/1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
|
Vascular disorders
Iliac occlusion
|
14.3%
1/7 • Number of events 1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
0.00%
0/1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
Other adverse events
| Measure |
Non-diabetic Patients Receiving the Resolute Stent
n=7 participants at risk
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
n=1 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
14.3%
1/7 • Number of events 1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
0.00%
0/1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
|
Renal and urinary disorders
Elevated creatinine
|
14.3%
1/7 • Number of events 1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
0.00%
0/1 • 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.
Participants were instructed to notify the research physician of any adverse effects of treatment, including those that are anticipated with this treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place