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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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This is a prospective study to analyze the outcome of provisional main vessel stenting on side branch by utilizing Two-Dimensional (2D) and Three-Dimensional (3D) frequency domain optical coherence tomography (FD-OCT). To analyze the fate of side-branch after provisional main vessel stenting based on morphology defined prior to PCI by OCT. Offline analysis of side branch impingement of the ostium of SB leading to acute loss in SB diameter area, carina shift and plaque shift will be also be performed.
Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned will be recruited. All the participants of the registry will receive same stent. OCT will be performed to analyze plaque morphology, SB size, SB angle and side branch ostial involvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Provisional stenting strategy | Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned. |
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| Measure | Description | Time Frame |
|---|---|---|
| MLD SB Diameter | Optical coherence tomography (OCT) - a high resolution intravascular imaging technique to assess side branch size. Side branch diameter will be measured by QAngio OCT software from Medis. Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Main vessel minimal lumen diameter (MLD) | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| SB Angle | Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch (SB) angle. Side branch angle will be measured by QAngio XA 3D software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Bifurcation angles (BA) | day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned
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| Name | Affiliation | Role |
|---|---|---|
| Annapoorna Kini, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27029714 | Result | Kini AS, Vengrenyuk Y, Pena J, Yoshimura T, Panwar SR, Motoyama S, Kezbor S, Hasan CM, Palkhiwala S, Kovacic JC, Moreno P, Baber U, Mehran R, Narula J, Sharma SK. Plaque morphology predictors of side branch occlusion after provisional stenting in coronary bifurcation lesion: Results of optical coherence tomography bifurcation study (ORBID). Catheter Cardiovasc Interv. 2017 Feb 1;89(2):259-268. doi: 10.1002/ccd.26524. Epub 2016 Mar 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Provisional Stenting Strategy | Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study group consisted of 30 patients with 30 bifurcation coronary lesions that did not involve SB ostium.
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| ID | Title | Description |
|---|---|---|
| BG000 | SB Ostium DS >50% | Side branch (SB) ostium diameter stenosis (DS) >50% |
| BG001 | SB Ostium DS ≤50% | Side branch (SB) ostium diameter stenosis (DS) ≤50% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MLD SB Diameter | Optical coherence tomography (OCT) - a high resolution intravascular imaging technique to assess side branch size. Side branch diameter will be measured by QAngio OCT software from Medis. Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Main vessel minimal lumen diameter (MLD) | Posted | Mean | Standard Error | mm | day 1 |
|
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Adverse events information not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SB Ostium DS >50% | Side branch (SB) ostium diameter stenosis (DS) >50% |
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Small number of cases. Results represent a hypothesis-generating pilot study rather than a definitive result.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Annapoorna Kini | Icahn School Of Medicine at Mount Sinai | annapoorna.kini@mountsinai.org |
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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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| SB Ostial Involvement | Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch ostial involvement. Side branch area will be measured by QAngio OCT software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Minimal lumen diameter (MLD) | day 1 |
| Diameter Stenosis (DS) | Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Side Branch Ostium Diameter Stenosis (DS). | day 1 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Hypertension | Number | participants |
|
| Dyslipidemia | Number | participants |
|
| Diabetes mellitus | Number | participants |
|
| Current smoking | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Prior MI | Prior myocardial infarction history | Number | participants |
|
| CCS angina grade III or IV | Canadian Cardiovascular Society (CCS) | Number | participants |
|
| Statin use | Number | participants |
|
| Antiplatelet therapy | Number | participants |
|
| Total cholesterol | Median | Inter-Quartile Range | mg/dL |
|
| HDL cholesterol | Median | Inter-Quartile Range | mg/dL |
|
| LDL cholesterol | Median | Inter-Quartile Range | mg/dL |
|
| Triglyceride | Median | Inter-Quartile Range | mg/dL |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | SB Angle | Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch (SB) angle. Side branch angle will be measured by QAngio XA 3D software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Bifurcation angles (BA) | Posted | Mean | Standard Error | degree | day 1 |
|
|
|
| Secondary | SB Ostial Involvement | Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch ostial involvement. Side branch area will be measured by QAngio OCT software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Minimal lumen diameter (MLD) | Posted | Mean | Standard Error | mm | day 1 |
|
|
|
| Secondary | Diameter Stenosis (DS) | Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Side Branch Ostium Diameter Stenosis (DS). | Posted | Mean | Standard Error | percentage of 100 | day 1 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | SB Ostium DS ≤50% | Side branch (SB) ostium diameter stenosis (DS) ≤50% | 0 | 0 | 0 | 0 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| PRE Distal BA |
|
| Post Distal BA |
|