Coronary Artery Disease
Conditions
Keywords
CAD
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Icahn School of Medicine at Mount Sinai
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Over 18 years of age presenting with stable coronary artery disease. * Angiographic lesion not involving side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited
Exclusion criteria
* Patient with lesion involving side branch ( \>70 %) by angiogram and need pre-dilation. * Patients with ostial left main artery lesions or ostial right coronary artery lesions * Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding * Known allergy to acetylsalicylic acid or clopidogrel. * Planned surgery within 12 months. * History of bleeding diathesis * Major surgery within 15 days * Life expectancy \< 12 months. * Patients with kidney dysfunction (CrCl\<30)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MLD SB Diameter | day 1 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SB Angle | day 1 | 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) |
| SB Ostial Involvement | day 1 | 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) |
| Diameter Stenosis (DS) | day 1 | Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Side Branch Ostium Diameter Stenosis (DS). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SB Ostium DS >50% Side branch (SB) ostium diameter stenosis (DS) \>50% | 10 |
| SB Ostium DS ≤50% Side branch (SB) ostium diameter stenosis (DS) ≤50% | 20 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | SB Ostium DS >50% | SB Ostium DS ≤50% |
|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 1.8 | 64.8 years STANDARD_DEVIATION 2.5 | 63.1 years STANDARD_DEVIATION 2.2 |
| Antiplatelet therapy Clopidogrel | 22 participants | 5 participants | 17 participants |
| Antiplatelet therapy Prasugrel | 4 participants | 3 participants | 1 participants |
| Antiplatelet therapy Ticagrelor | 4 participants | 2 participants | 2 participants |
| BMI | 30.3 kg/m^2 STANDARD_DEVIATION 1.6 | 27.8 kg/m^2 STANDARD_DEVIATION 2 | 31.5 kg/m^2 STANDARD_DEVIATION 2.2 |
| CCS angina grade III or IV no | 4 participants | 2 participants | 2 participants |
| CCS angina grade III or IV yes | 26 participants | 8 participants | 18 participants |
| Current smoking no | 26 participants | 8 participants | 18 participants |
| Current smoking yes | 4 participants | 2 participants | 2 participants |
| Diabetes mellitus no | 17 participants | 5 participants | 12 participants |
| Diabetes mellitus yes | 13 participants | 5 participants | 8 participants |
| Dyslipidemia no | 2 participants | 1 participants | 1 participants |
| Dyslipidemia yes | 28 participants | 9 participants | 19 participants |
| HDL cholesterol | 41 mg/dL | 41 mg/dL | 40 mg/dL |
| Hypertension no | 6 participants | 1 participants | 5 participants |
| Hypertension yes | 24 participants | 9 participants | 15 participants |
| LDL cholesterol | 72 mg/dL | 72 mg/dL | 73 mg/dL |
| Prior MI no | 26 participants | 9 participants | 17 participants |
| Prior MI yes | 4 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 9 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 21 Participants | 7 Participants | 14 Participants |
| Statin use no | 6 participants | 2 participants | 4 participants |
| Statin use yes | 24 participants | 8 participants | 16 participants |
| Total cholesterol | 136 mg/dL | 136 mg/dL | 136 mg/dL |
| Triglyceride | 102 mg/dL | 107 mg/dL | 84 mg/dL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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)
Time frame: day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB Ostium DS >50% | MLD SB Diameter | PRE | 08. mm | Standard Error 0.1 |
| SB Ostium DS >50% | MLD SB Diameter | POST | 2.3 mm | Standard Error 0.1 |
| SB Ostium DS ≤50% | MLD SB Diameter | PRE | 1.0 mm | Standard Error 0.1 |
| SB Ostium DS ≤50% | MLD SB Diameter | POST | 2.2 mm | Standard Error 0.1 |
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).
Time frame: day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB Ostium DS >50% | Diameter Stenosis (DS) | PRE DS | 30.0 percentage of 100 | Standard Error 4.1 |
| SB Ostium DS >50% | Diameter Stenosis (DS) | POST DS | 63.1 percentage of 100 | Standard Error 2.6 |
| SB Ostium DS ≤50% | Diameter Stenosis (DS) | PRE DS | 24.0 percentage of 100 | Standard Error 3.2 |
| SB Ostium DS ≤50% | Diameter Stenosis (DS) | POST DS | 27.7 percentage of 100 | Standard Error 3.5 |
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)
Time frame: day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB Ostium DS >50% | SB Angle | PRE Proximal BA | 140.3 degree | Standard Error 6 |
| SB Ostium DS >50% | SB Angle | PRE Distal BA | 48.0 degree | Standard Error 3.6 |
| SB Ostium DS >50% | SB Angle | POST Proximal BA | 140.5 degree | Standard Error 7.2 |
| SB Ostium DS >50% | SB Angle | Post Distal BA | 47.9 degree | Standard Error 4.8 |
| SB Ostium DS ≤50% | SB Angle | POST Proximal BA | 141.5 degree | Standard Error 3.7 |
| SB Ostium DS ≤50% | SB Angle | PRE Proximal BA | 147.7 degree | Standard Error 4 |
| SB Ostium DS ≤50% | SB Angle | Post Distal BA | 48.3 degree | Standard Error 2.6 |
| SB Ostium DS ≤50% | SB Angle | PRE Distal BA | 49.9 degree | Standard Error 2.8 |
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)
Time frame: day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB Ostium DS >50% | SB Ostial Involvement | PRE side branch ostium MLD | 1.4 mm | Standard Error 0.3 |
| SB Ostium DS >50% | SB Ostial Involvement | POST side branch ostium MLD | 0.8 mm | Standard Error 0.1 |
| SB Ostium DS ≤50% | SB Ostial Involvement | PRE side branch ostium MLD | 1.6 mm | Standard Error 0.1 |
| SB Ostium DS ≤50% | SB Ostial Involvement | POST side branch ostium MLD | 1.8 mm | Standard Error 0.1 |