Trial Outcomes & Findings for Side Branch FFR After Provisional Stenting (NCT NCT03115580)
NCT ID: NCT03115580
Last Updated: 2020-05-14
Results Overview
Number of participants with Side Branch (SB) compromise which is defined as SB DS \> 70%, or dissection or TIMI \< 3
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
Day 1
Results posted on
2020-05-14
Participant Flow
Participants enrolled between May 2017 and March 2019.
Participant milestones
| Measure |
Rotational Atherectomy
Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the "snow plow" effect.
|
CBA/PTCA
Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)
Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
|
Overall Study
COMPLETED
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Rotational Atherectomy
n=35 Participants
Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the "snow plow" effect.
|
CBA/PTCA
n=36 Participants
Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)
Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 10.5 • n=35 Participants
|
66.6 years
STANDARD_DEVIATION 9.9 • n=36 Participants
|
67.2 years
STANDARD_DEVIATION 10.1 • n=71 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=35 Participants
|
14 Participants
n=36 Participants
|
21 Participants
n=71 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=35 Participants
|
22 Participants
n=36 Participants
|
50 Participants
n=71 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Diabetes Mellitus
|
11 Participants
n=35 Participants
|
14 Participants
n=36 Participants
|
25 Participants
n=71 Participants
|
|
Hypertension
|
28 Participants
n=35 Participants
|
30 Participants
n=36 Participants
|
58 Participants
n=71 Participants
|
|
Hyperlipidemia
|
32 Participants
n=35 Participants
|
29 Participants
n=36 Participants
|
61 Participants
n=71 Participants
|
|
Current smoker
|
5 Participants
n=35 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=71 Participants
|
|
Previous myocardial infarction
|
7 Participants
n=35 Participants
|
3 Participants
n=36 Participants
|
10 Participants
n=71 Participants
|
|
Prior percutaneous coronary intervention
|
13 Participants
n=35 Participants
|
14 Participants
n=36 Participants
|
27 Participants
n=71 Participants
|
|
Prior coronary artery bypass graft surgery
|
0 Participants
n=35 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=71 Participants
|
|
CCS angina grade III or IV
|
14 Participants
n=35 Participants
|
13 Participants
n=36 Participants
|
27 Participants
n=71 Participants
|
|
Body mass index,
|
29.0 kg/m^2
STANDARD_DEVIATION 4.6 • n=35 Participants
|
30.2 kg/m^2
STANDARD_DEVIATION 7.2 • n=36 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 6.0 • n=71 Participants
|
|
Multivessel disease
|
21 Participants
n=35 Participants
|
17 Participants
n=36 Participants
|
38 Participants
n=71 Participants
|
|
Bifurcation location
LAD/Diagonal
|
33 Participants
n=35 Participants
|
36 Participants
n=36 Participants
|
69 Participants
n=71 Participants
|
|
Bifurcation location
LCX/OM
|
2 Participants
n=35 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=71 Participants
|
|
Calcification
Moderate
|
25 Participants
n=35 Participants
|
27 Participants
n=36 Participants
|
52 Participants
n=71 Participants
|
|
Calcification
Severe
|
10 Participants
n=35 Participants
|
9 Participants
n=36 Participants
|
19 Participants
n=71 Participants
|
PRIMARY outcome
Timeframe: Day 1Number of participants with Side Branch (SB) compromise which is defined as SB DS \> 70%, or dissection or TIMI \< 3
Outcome measures
| Measure |
Rotational Atherectomy
n=35 Participants
Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the "snow plow" effect.
|
CBA/PTCA
n=36 Participants
Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)
Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon
|
|---|---|---|
|
Number of Participants With Side Branch Compromise
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1Number of participants with SB dissection
Outcome measures
| Measure |
Rotational Atherectomy
n=35 Participants
Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the "snow plow" effect.
|
CBA/PTCA
n=36 Participants
Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)
Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon
|
|---|---|---|
|
Number of Participants With SB Dissection
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Number of participants with TIMI flow grade \< 3
Outcome measures
| Measure |
Rotational Atherectomy
n=35 Participants
Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the "snow plow" effect.
|
CBA/PTCA
n=36 Participants
Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)
Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon
|
|---|---|---|
|
Number of Participants With TIMI < 3
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1Number of participants with Side Branch Diameter Stenosis (DS) \> 70%
Outcome measures
| Measure |
Rotational Atherectomy
n=35 Participants
Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the "snow plow" effect.
|
CBA/PTCA
n=36 Participants
Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)
Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon
|
|---|---|---|
|
Number of Participants With SB DS >70%
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1Number of Participants with successfully deliver Fractional Flow Reserve (FFR) wire to desired SB distal segment
Outcome measures
| Measure |
Rotational Atherectomy
n=35 Participants
Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the "snow plow" effect.
|
CBA/PTCA
n=36 Participants
Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)
Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon
|
|---|---|---|
|
Number of Participants With FFR Device Success
|
28 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Day 1FFR Wire Workhorse Capability - Number of patients in which FFR wire was able to serve as rail to deliver additional interventional devices to target SB lesion
Outcome measures
| Measure |
Rotational Atherectomy
n=35 Participants
Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the "snow plow" effect.
|
CBA/PTCA
n=36 Participants
Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)
Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon
|
|---|---|---|
|
Number of Patients With FFR Wire Workhorse Capability
|
0 Participants
|
0 Participants
|
Adverse Events
Rotational Atherectomy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CBA/PTCA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rotational Atherectomy
n=35 participants at risk
Rotational atherectomy (RA) for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the "snow plow" effect.
|
CBA/PTCA
n=36 participants at risk
Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)
Cutting Balloon Angioplasty: Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
0.00%
0/35 • 1 Day
|
2.8%
1/36 • 1 Day
|
|
Cardiac disorders
Transient sidebranch closing
|
0.00%
0/35 • 1 Day
|
2.8%
1/36 • 1 Day
|
|
Surgical and medical procedures
LM dissection with contrast injecting
|
2.9%
1/35 • 1 Day
|
0.00%
0/36 • 1 Day
|
|
Surgical and medical procedures
Right CFA access side bleeding
|
2.9%
1/35 • 1 Day
|
0.00%
0/36 • 1 Day
|
|
Cardiac disorders
Dissection Minor
|
2.9%
1/35 • 1 Day
|
0.00%
0/36 • 1 Day
|
|
Cardiac disorders
Side branch closure
|
2.9%
1/35 • 1 Day
|
0.00%
0/36 • 1 Day
|
|
Cardiac disorders
Staged PCI pf p:CS-OM1
|
2.9%
1/35 • 1 Day
|
0.00%
0/36 • 1 Day
|
Additional Information
Annapoorna S. Kini, MD
Icahn School of Medicine at Mount Sinai
Phone: 212-241-4181
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place