An observational study in Coronary Artery Disease, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-07-07.
Sponsored by Icahn School of Medicine at Mount Sinai · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 30 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned
Exclusion Criteria:
Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned.
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
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
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
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
| Milestone | Provisional Stenting Strategy |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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)
| mm | SB Ostium DS >50% | SB Ostium DS ≤50% |
|---|---|---|
| PRE | 08. ± 0.1 | 1.0 ± 0.1 |
| POST | 2.3 ± 0.1 | 2.2 ± 0.1 |
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)
| degree | SB Ostium DS >50% | SB Ostium DS ≤50% |
|---|---|---|
| PRE Proximal BA | 140.3 ± 6.0 | 147.7 ± 4.0 |
| POST Proximal BA | 140.5 ± 7.2 | 141.5 ± 3.7 |
| PRE Distal BA | 48.0 ± 3.6 | 49.9 ± 2.8 |
| Post Distal BA | 47.9 ± 4.8 | 48.3 ± 2.6 |
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)
| mm | SB Ostium DS >50% | SB Ostium DS ≤50% |
|---|---|---|
| PRE side branch ostium MLD | 1.4 ± 0.3 | 1.6 ± 0.1 |
| POST side branch ostium MLD | 0.8 ± 0.1 | 1.8 ± 0.1 |
Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Side Branch Ostium Diameter Stenosis (DS).
| percentage of 100 | SB Ostium DS >50% | SB Ostium DS ≤50% |
|---|---|---|
| PRE DS | 30.0 ± 4.1 | 24.0 ± 3.2 |
| POST DS | 63.1 ± 2.6 | 27.7 ± 3.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SB Ostium DS >50% | — | — | — |
| SB Ostium DS ≤50% | — | — | — |
The study group consisted of 30 patients with 30 bifurcation coronary lesions that did not involve SB ostium.
| Age, Continuous(years) | SB Ostium DS >50% | SB Ostium DS ≤50% | Total |
|---|---|---|---|
| Mean | 64.8 ± 2.5 | 63.1 ± 2.2 | 63.6 ± 1.8 |
| Sex: Female, Male(Participants) | SB Ostium DS >50% | SB Ostium DS ≤50% | Total |
|---|---|---|---|
| Female | 3 | 6 | 9 |
| Male | 7 | 14 | 21 |
| Hypertension(participants) | SB Ostium DS >50% | SB Ostium DS ≤50% | Total |
|---|---|---|---|
| yes | 9 | 15 | 24 |
| no | 1 | 5 | 6 |
| Dyslipidemia(participants) | SB Ostium DS >50% | SB Ostium DS ≤50% | Total |
|---|---|---|---|
| yes | 9 | 19 | 28 |
| no | 1 | 1 | 2 |
| Diabetes mellitus(participants) | SB Ostium DS >50% | SB Ostium DS ≤50% | Total |
|---|---|---|---|
| yes | 5 | 8 | 13 |
| no | 5 | 12 | 17 |
| Current smoking(participants) | SB Ostium DS >50% | SB Ostium DS ≤50% | Total |
|---|---|---|---|
| yes | 2 | 2 | 4 |
| no | 8 | 18 | 26 |
| BMI(kg/m^2) | SB Ostium DS >50% | SB Ostium DS ≤50% | Total |
|---|---|---|---|
| Mean | 27.8 ± 2.0 | 31.5 ± 2.2 | 30.3 ± 1.6 |
| Prior MI(participants) | SB Ostium DS >50% | SB Ostium DS ≤50% | Total |
|---|---|---|---|
| yes | 1 | 3 | 4 |
| no | 9 | 17 | 26 |
7 further baseline measures are reported on the registry.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai