Ignite Creation Date:
2024-05-06 @ 1:24 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01794949
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2012-11-07
Brief Title:
Optical Frequency Domain Imaging OFDI and Vascular Healing After Stent Placement
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Optical Frequency Domain Imaging OFDI Determined Stent Strut Coverage and Plaque Morphology After RESOLUTE Stent Placement in Non-Insulin Dependent Diabetics Presenting With Acute Coronary Syndrome ACS
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OFDI-DM
Brief Summary:
The use of drug eluting stents DES used to treat coronary artery blockages is limited by poor healing of the stented area This will require the combined use of blood thinners such as aspirin and clopidogrel ie dual anti-platelet therapy DAPT to prevent complications such as clot formation on the stent which may lead to a heart attack Diabetic patients and those presenting with a heart attack at the time of stent placement are at increased risk for clot formation However little is known of the healing responses after stent placement in these populations
Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both clot formation and potential bleeding from the blood thinners thereby improving the long-term safety of DES
Intracoronary optical frequency domain imaging OFDI is a novel high resolution invasive imaging technique that has the ability to evaluate stent healing at follow-up Among the commercially available coated stents used in the US the zotarolimus eluting stents RESOLUTE Integrity Medtronic Minneapolis MN has demonstrated superior healing in both preclinical and clinical studies
The purpose of this trial is to determine the healing responses of the RESOLUTE Integrity stent as detected by OFDI in patients with and without diabetes presenting with ACS Specifically in this observational study the study team will investigate non-insulin dependent diabetics and non-diabetics in the setting of ACS and RESOLUTE Integrity stent placement
The investigators hypothesize that healing responses in patients with non-insulin dependent diabetes will be similar to those without diabetes presenting with ACS and that a majority of patients will demonstrate complete healing as determined by OFDI measurements
Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both clot formation and potential bleeding from the blood thinners thereby improving the long-term safety of DES
Intracoronary optical frequency domain imaging OFDI is a novel high resolution invasive imaging technique that has the ability to evaluate stent healing at follow-up Among the commercially available coated stents used in the US the zotarolimus eluting stents RESOLUTE Integrity Medtronic Minneapolis MN has demonstrated superior healing in both preclinical and clinical studies
The purpose of this trial is to determine the healing responses of the RESOLUTE Integrity stent as detected by OFDI in patients with and without diabetes presenting with ACS Specifically in this observational study the study team will investigate non-insulin dependent diabetics and non-diabetics in the setting of ACS and RESOLUTE Integrity stent placement
The investigators hypothesize that healing responses in patients with non-insulin dependent diabetes will be similar to those without diabetes presenting with ACS and that a majority of patients will demonstrate complete healing as determined by OFDI measurements
Detailed Description:
The long-term efficacy of drug eluting stents DES used to treat symptomatic coronary artery disease is limited by incomplete healing of the stented segment necessitating the use of dual anti-platelet therapy DAPT with aspirin and a thienopyridine to prevent these late thrombotic complications Diabetic patients and those presenting with acute coronary syndrome ACS at the time of DES placement are at increased risk for late in stent thrombosis however little is known of the healing responses in these populations
Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both thrombosis and bleeding thereby improving the long-term safety of DES Intracoronary optical frequency domain imaging OFDI is a novel high resolution invasive imaging modality with the potential to discern plaque morphology at stent placement and stent strut healing at follow-up Among the commercially available coated stents used in the US the zotarolimus eluting stents RESOLUTE Medtronic Minneapolis MN has demonstrated superior endothelialization and long term safety data in both preclinical and clinical studies
The purpose of this trial is to determine the healing responses to the RESOLUTE stent as detected by OFDI in patients with and without diabetes presenting with ACS Specifically investigators will 1 determine while using OFDI whether any difference in healing occurs in non-insulin dependent diabetic patients presenting with ACS after RESOLUTE stent placement at 6 months 2 determine how initial plaque morphology and angiographic measures such as late loss correlate with stent strut healing and 3 examine whether selected biomarkers have an utility in predicting stent strut healing by OFDI
Investigators will conduct a clinical study that images subjects at baseline and at 6 months after stent placement with intracoronary OFDI OFDI data will be utilized to determine plaque morphology prior to intervention ensure adequate strut apposition and stent sizing immediately post deployment and to measure stent strut coverage at 6 month follow-up Two follow-up imaging passes will be conducted to evaluate test-retest variability of the coverage measurement In addition to assessing the feasibility of using the OFDI coverage metric in vivo this data may provide information on the magnitude of coverage that can be expected at 6 months following RESOLUTE stents
Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both thrombosis and bleeding thereby improving the long-term safety of DES Intracoronary optical frequency domain imaging OFDI is a novel high resolution invasive imaging modality with the potential to discern plaque morphology at stent placement and stent strut healing at follow-up Among the commercially available coated stents used in the US the zotarolimus eluting stents RESOLUTE Medtronic Minneapolis MN has demonstrated superior endothelialization and long term safety data in both preclinical and clinical studies
The purpose of this trial is to determine the healing responses to the RESOLUTE stent as detected by OFDI in patients with and without diabetes presenting with ACS Specifically investigators will 1 determine while using OFDI whether any difference in healing occurs in non-insulin dependent diabetic patients presenting with ACS after RESOLUTE stent placement at 6 months 2 determine how initial plaque morphology and angiographic measures such as late loss correlate with stent strut healing and 3 examine whether selected biomarkers have an utility in predicting stent strut healing by OFDI
Investigators will conduct a clinical study that images subjects at baseline and at 6 months after stent placement with intracoronary OFDI OFDI data will be utilized to determine plaque morphology prior to intervention ensure adequate strut apposition and stent sizing immediately post deployment and to measure stent strut coverage at 6 month follow-up Two follow-up imaging passes will be conducted to evaluate test-retest variability of the coverage measurement In addition to assessing the feasibility of using the OFDI coverage metric in vivo this data may provide information on the magnitude of coverage that can be expected at 6 months following RESOLUTE stents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None