Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement Diabetics Presenting With Acute Coronary Syndrome
This trial is active, not recruiting.
|Condition||coronary artery disease|
|Treatment||resolute integrity stent|
|Start date||September 2013|
|End date||July 2016|
|Trial size||8 participants|
|Trial identifier||NCT01794949, IRB00057208|
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 (i.e. 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 the stent 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 U.S., 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 to the RESOLUTE Intregrity stent as detected by OFDI in patients with and without diabetes presenting with ACS. Specifically in this observational study, we 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.
|Observational model||case control|
Percent stent coverage
time frame: 6 months
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Any patient requiring PTCI for acute coronary syndrome (ACS) and meeting criteria (as determined by the performing physician) for Resolute Integrity stent placement. Exclusion Criteria: - ST segment elevation MI (STEMI) - stable angina - current or planned pregnancy (for women of childbearing age) - treatment of > 2 lesions during the index hospitalization - insulin dependent diabetic patients at the time of stent placement - use of overlapping stents.
|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)|
|Principal investigator||Henry Liberman, MD|
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