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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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The purpose of this study is to determine whether co-registration of OCT and angiography reduce geographic miss defined as stent edge dissection or significant residual stenosis at stent edge after stent implantation during percutaneous coronary intervention.
Background: When a stent fails to fully cover the lesion, it is termed "geographic miss" (GM). Optical coherence tomography (OCT) is an intracoronary imaging modality that has higher resolution than conventional intracoronary ultrasound. Although OCT allows identification of the location of the culprit lesion and side branch using automated measures, it is sometimes difficult to identify the exact segment corresponding to angiography. Recently, co-registration of OCT and angiography has become available; however, whether this reduces the incidence of GM during stenting is unknown.
Hypothesis: OCT reduces GM during percutaneous coronary intervention.
Objectives:
Determine the incidence of GM defined as residual disease* and significant edge dissection† at proximal and distal reference
Determine the incidence of stent dislocation (distance between planned and actual stented place)
Determine procedural findings (additional stent, total fluoro time, total contrast volume)
Minimum lumen area <4.0 mm2 in the presence of significant residual plaque within 5 mm distal and proximal to the stent edge.
Sample size considerations: OCT with co-registration: 100, OCT without co-registration: 100 (α=0.05, β =0.2). In a retrospective evaluation, the incidence of residual disease (lumen area <4.0 mm2 in the presence of significant residual plaque) or significant stent edge dissection was 36% (18/50, 34% [17/50] with residual stenosis, 4% [2/50] with significant edge dissection). Under the assumption that GM occurs in 36% of patients without co-registration and 18% of patients with co-registration, a group of 190 patients yields a power 80% (with a 2-sided α=0.05) to detect a difference in GM between patients with and without co-registration. In order to account for patient drop out and non-evaluable OCT recordings (5%), a total of 200 patients will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary PCI with OCT with Co-Registration | Active Comparator | Coronary stenting will be performed with OCT guidance as per local practice. Pre and post stenting procedure will be performed with OCT guidance with the use of the Co-Registration software tool after stent implanted. |
|
| Coronary PCI with OCT without Co-Registration | Placebo Comparator | Coronary stenting will be performed with OCT guidance as per local practice. Pre and post stenting procedure will be performed with OCT guidance without the use of the Co-Registration software tool after stent implanted. I |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary PCI with OCT with Co Registration | Procedure | Co-Registration is an online tool used to take measurements during a stent procedure ( PCI-percutaneous coronary intervention) as part of the OCT ( Optical Coherence Tomography intravascular system. Co Registration software may provide additional imaging details during stent implantation when using OCT. |
| Measure | Description | Time Frame |
|---|---|---|
| Geographic miss | Geographic miss defined as evidence of residual disease at stent edge or significant edge dissection after stent deployment | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Residual disease at stented edge | Residual disease at stent edge will defined as minimum lumen area within 5mm from the stent edge evaluated by OCT. This measurement will be analyzed by a core lab independently who will be blinded for randomization. | Intraoperative |
| Number of participants with stent edge dissection |
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Inclusion Criteria:
• Patients ≥18 years old who undergo percutaneous coronary intervention per clinical indications.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard A Shlofmitz, MD | Contact | 516-390-9640 | richard.shlofmitz@chsli.org | |
| Elizabeth S Haag, RN MPA | Contact | 516 562-6790 | elizabeth.haag@chsli.org |
| Name | Affiliation | Role |
|---|---|---|
| Richard A Shlofmitz, MD | Chairman of Cardiology St Francis Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Francis Hospital | Recruiting | Roslyn | New York | 11576 | United States |
Presently not a plan to share data
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Coronary PCI with OCT without Co Registration | Procedure | Coronary PCI will be performed using OCT ( Optical Coherence Tomography intravascular system) guidance without the Co Registration software tool enabled. |
|
Stent edge dissection will be defied as a flap of vessel wall and further categorized as intimal dissection, medial dissection, intramural hematoma, or extra-medial dissection. Minimum lumen area, angle of dissection flap, and length of dissection will be measured by OCT by a core lab who is blinded to the randomization. |
| peri procedure |
| Distance between the planned and actual stent location | Distance between the planned and actual stent location will be defined as the distance between the center of planned stent location and the center of actual stent location which will be recorded on the OCT software and analyzed by a core lab who is blinded to the randomization. | Intraoperative |
| Number of additional stents required | This will be measured as number of participants with additional stent required. | Intraoperative |
| Procedure time | time of PCI procedure defined as time vascular access obtained until guide catheter removed from access site. | Intraoperative |
| Total fluoroscopy time | total amount of fluoroscopy time used during procedure | intraoperative |
| Total contrast volume | total mount of contrast in ml used during entire PCI procedure | intraoperative |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |