Trial Outcomes & Findings for Single-centre, Registry Trial, the Patients Presented With Stable Coronary Artery Disease (NCT NCT02364778)
NCT ID: NCT02364778
Last Updated: 2016-07-07
Results Overview
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)
COMPLETED
30 participants
day 1
2016-07-07
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single-centre, Registry Trial, the Patients Presented With Stable Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
SB Ostium DS >50%
n=10 Participants
Side branch (SB) ostium diameter stenosis (DS) \>50%
|
SB Ostium DS ≤50%
n=20 Participants
Side branch (SB) ostium diameter stenosis (DS) ≤50%
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 2.5 • n=99 Participants
|
63.1 years
STANDARD_DEVIATION 2.2 • n=107 Participants
|
63.6 years
STANDARD_DEVIATION 1.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Hypertension
yes
|
9 participants
n=99 Participants
|
15 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Hypertension
no
|
1 participants
n=99 Participants
|
5 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Dyslipidemia
yes
|
9 participants
n=99 Participants
|
19 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Dyslipidemia
no
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Diabetes mellitus
yes
|
5 participants
n=99 Participants
|
8 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Diabetes mellitus
no
|
5 participants
n=99 Participants
|
12 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Current smoking
yes
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Current smoking
no
|
8 participants
n=99 Participants
|
18 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
BMI
|
27.8 kg/m^2
STANDARD_DEVIATION 2.0 • n=99 Participants
|
31.5 kg/m^2
STANDARD_DEVIATION 2.2 • n=107 Participants
|
30.3 kg/m^2
STANDARD_DEVIATION 1.6 • n=206 Participants
|
|
Prior MI
yes
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Prior MI
no
|
9 participants
n=99 Participants
|
17 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
CCS angina grade III or IV
yes
|
8 participants
n=99 Participants
|
18 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
CCS angina grade III or IV
no
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Statin use
yes
|
8 participants
n=99 Participants
|
16 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Statin use
no
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Antiplatelet therapy
Clopidogrel
|
5 participants
n=99 Participants
|
17 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Antiplatelet therapy
Prasugrel
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Antiplatelet therapy
Ticagrelor
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Total cholesterol
|
136 mg/dL
n=99 Participants
|
136 mg/dL
n=107 Participants
|
136 mg/dL
n=206 Participants
|
|
HDL cholesterol
|
41 mg/dL
n=99 Participants
|
40 mg/dL
n=107 Participants
|
41 mg/dL
n=206 Participants
|
|
LDL cholesterol
|
72 mg/dL
n=99 Participants
|
73 mg/dL
n=107 Participants
|
72 mg/dL
n=206 Participants
|
|
Triglyceride
|
107 mg/dL
n=99 Participants
|
84 mg/dL
n=107 Participants
|
102 mg/dL
n=206 Participants
|
PRIMARY outcome
Timeframe: day 1Optical 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)
Outcome measures
| Measure |
SB Ostium DS >50%
n=10 Participants
Side branch (SB) ostium diameter stenosis (DS) \>50%
|
SB Ostium DS ≤50%
n=20 Participants
Side branch (SB) ostium diameter stenosis (DS) ≤50%
|
|---|---|---|
|
MLD SB Diameter
PRE
|
08. mm
Standard Error 0.1
|
1.0 mm
Standard Error 0.1
|
|
MLD SB Diameter
POST
|
2.3 mm
Standard Error 0.1
|
2.2 mm
Standard Error 0.1
|
SECONDARY outcome
Timeframe: day 1Optical 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)
Outcome measures
| Measure |
SB Ostium DS >50%
n=10 Participants
Side branch (SB) ostium diameter stenosis (DS) \>50%
|
SB Ostium DS ≤50%
n=20 Participants
Side branch (SB) ostium diameter stenosis (DS) ≤50%
|
|---|---|---|
|
SB Angle
PRE Proximal BA
|
140.3 degree
Standard Error 6.0
|
147.7 degree
Standard Error 4.0
|
|
SB Angle
POST Proximal BA
|
140.5 degree
Standard Error 7.2
|
141.5 degree
Standard Error 3.7
|
|
SB Angle
PRE Distal BA
|
48.0 degree
Standard Error 3.6
|
49.9 degree
Standard Error 2.8
|
|
SB Angle
Post Distal BA
|
47.9 degree
Standard Error 4.8
|
48.3 degree
Standard Error 2.6
|
SECONDARY outcome
Timeframe: day 1Optical 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)
Outcome measures
| Measure |
SB Ostium DS >50%
n=10 Participants
Side branch (SB) ostium diameter stenosis (DS) \>50%
|
SB Ostium DS ≤50%
n=20 Participants
Side branch (SB) ostium diameter stenosis (DS) ≤50%
|
|---|---|---|
|
SB Ostial Involvement
PRE side branch ostium MLD
|
1.4 mm
Standard Error 0.3
|
1.6 mm
Standard Error 0.1
|
|
SB Ostial Involvement
POST side branch ostium MLD
|
0.8 mm
Standard Error 0.1
|
1.8 mm
Standard Error 0.1
|
SECONDARY outcome
Timeframe: day 1Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Side Branch Ostium Diameter Stenosis (DS).
Outcome measures
| Measure |
SB Ostium DS >50%
n=10 Participants
Side branch (SB) ostium diameter stenosis (DS) \>50%
|
SB Ostium DS ≤50%
n=20 Participants
Side branch (SB) ostium diameter stenosis (DS) ≤50%
|
|---|---|---|
|
Diameter Stenosis (DS)
PRE DS
|
30.0 percentage of 100
Standard Error 4.1
|
24.0 percentage of 100
Standard Error 3.2
|
|
Diameter Stenosis (DS)
POST DS
|
63.1 percentage of 100
Standard Error 2.6
|
27.7 percentage of 100
Standard Error 3.5
|
Adverse Events
SB Ostium DS >50%
SB Ostium DS ≤50%
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place