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Parameter
Calcification Length (mm), Mean ± StdDev (N)
Bifurcation/Trifurcation, % (n/N)
LAD = left anterior descending coronary artery; RCA = right coronary artery;
RVD = reference vessel diameter; MLD = minimal lumen diameter;
StdDev = standard deviation
1. Interpolated
A summary of post-IVL and post-stent angiography as
determined by the Core Lab for pivotal subjects is provided
in Table 3.
Table 3. Post-IVL and Post-Stent Angiography (Core Lab)
(Pivotal Analysis Set)
Parameter
Post-IVL
MLD (mm), Mean ± StdDev (N)
1.87 ± 0.48 (341)
% Diameter Stenosis, Mean ± StdDev (N)
37.2 ± 13.5 (341)
Acute Gain (mm), Mean ± StdDev (N)
0.82 ± 0.48 (339)
MLD = minimal lumen diameter; StdDev = standard deviation
Per the Disrupt CAD III protocol, all subjects required at
least one stent to be placed after IVL treatment; 99.2% of
pivotal subjects (381/384) received a stent.
The Primary Safety results on the Pivotal Analysis Set are
summarized in Table 4. Among 383 pivotal subjects with
evaluable primary safety endpoint data, the observed
30-day MACE free rate was 92.2% (353/383), with the
corresponding one-sided lower 95% confidence limit of
89.9%, which was higher than the PG of 84.4%. The
Primary Safety Endpoint was met based on the Pivotal
Analysis Set (p<0.0001).
Table 4. Primary Safety Endpoint (30-day MACE)
(Pivotal Analysis Set)
% (n/N)
Primary Safety
[95% Lower
Hypothesis
Endpoint
Confidence
Interval]
1
Freedom from
92.2%
H
: π
≤84.4%
0
s
MACE
within
(353/383)
H
: π
3
4
>84.4%
A
s
30 days post-
[89.9%]
procedure
1. 95% lower confidence interval is calculated based on a one-sided asymptotic
Wald (normal approximation-based) confidence interval for a binomial
proportion. The standard error is calculated from the sample proportion.
2. P-value is calculated based on a one-sided asymptotic Wald (normal
approximation-based) test for a binomial proportion at a 0.05 level of
significance. The standard error is calculated from the sample proportion.
3. All MACE were adjudicated by an independent CEC. If full data were not
available, the event was adjudicated based on the clinical judgement of the
independent CEC. Missing data were not imputed and a sensitivity analysis was
performed to assess endpoint robustness.
4. One subject was excluded from the primary safety endpoint analysis due to
insufficient follow-up (< 23 days).
LBL 64191 Rev D, Instructions for Use ( June 2023)
The components of the Primary Safety Endpoint are
Pivotal
(N=384)
provided in Table 5 below.
47.85 ± 18.81 (384)
29.9% (115/384)
Table 5. Primary Safety Endpoint Components (Pivotal
Analysis Set)
Cumulative MACE Rates
MACE
2,3
Cardiac Death
Non-Q-wave MI
4
Q-wave MI
Target Vessel Revascularization
1. One subject was excluded from the primary safety endpoint analysis due to
insufficient follow-up (<23 days).
2. All MACE were adjudicated by an independent CEC. If full data were not available,
Pivotal (N=384)
the event was adjudicated based on the clinical judgement of the independent
Post-Stent
CEC. Missing data were not imputed and a sensitivity analysis was performed
(In-Stent)
to assess endpoint robustness.
2.74 ± 0.43 (381)
3. Some subjects failed >1 component of the MACE criteria; therefore, the categories
are not mutually exclusive.
11.9 ± 7.1 (381)
4. Myocardial Infarction (MI) is defined as CK-MB level >3 times the upper limit
1.68 ± 0.46 (378)
of lab normal (ULN) value with or without new pathologic Q wave at discharge
(periprocedural MI) and using the Fourth Universal Definition of Myocardial
Infarction beyond discharge (spontaneous MI).
The Primary Effectiveness results on the Pivotal Analysis Set
are summarized in Table 6. No pivotal subjects were
missing data required to define Procedural Success (data
related to stent delivery or final residual stenosis) and
therefore all pivotal subjects were included in the primary
effectiveness analysis (n=384). The observed procedural
success rate was 92.4% (355/384), with the corresponding
one-sided lower 95% confidence limit of 90.2%, which was
higher than the PG of 83.4%. Therefore, the Primary
Effectiveness Endpoint was met based on the Pivotal
Analysis Set (p<0.0001).
Table 6. Primary Effectiveness Endpoint (Pivotal Analysis Set)
Primary
[95% Lower
Effectiveness
Endpoint
P value
Conclusion
2
Procedural
92.4% (355/384)
Success
3
<0.0001
Performance
Goal Met
1. 95% lower confidence interval is calculated based on a one-sided asymptotic
Wald (normal approximation-based) confidence interval for a binomial
proportion. The standard error is calculated from the sample proportion.
2. P-value is calculated based on a one-sided asymptotic Wald (normal
approximation-based) test for a binomial proportion at a 0.05 level of
significance. The standard error is calculated from the sample proportion.
3. Procedural Success defined as stent delivery with a residual in-stent stenosis
<50% (core laboratory assessed) and without in-hospital MACE (CEC adjudicated).
The components of the Primary Effectiveness Endpoint are
provided in Table 7 below.
Table 7. Primary Effectiveness Endpoint Components
(Pivotal Analysis Set)
Primary Effectiveness Endpoint: Procedural Success
Procedural Success
Stent Delivered
3
<50% Residual Stenosis
Without In-Hospital MACE
In-Hospital
30-Day Follow-up
N=384
N=383
1
7.0% (27/384)
7.8% (30/383)
0.3% (1/384)
0.5% (2/383)
5.7% (22/384)
6.0% (23/383)
1.0% (4/384)
1.6% (6/383)
0.5% (2/384)
1.6% (6/383)
% (n/N)
Hypothesis
P value
Conclusion
2
Confidence
Interval]
1
H
: π
Performance
≤83.4%
<0.0001
0
s
[90.2%]
H
: π
>83.4%
Goal Met
A
s
N (%)
92.4% (355/384)
1,2
99.2% (381/384)
100.0% (381/381)
93.0% (357/384)
EN
Primary Effectiveness Endpoint: Procedural Success
1. Procedural Success defined as stent delivery with a residual in-stent stenosis
<50% (core laboratory assessed) and without in-hospital MACE (CEC
adjudicated).
2. Some subjects failed >1 component of the Procedural Success criteria; therefore,
the categories are not mutually exclusive.
3. Three subjects did not receive a stent; two were IVL Device Delivery Failures that
did not receive any therapy on the day of the index procedure and one subject
had failed stent delivery after successful IVL.
Table 8 provides a summary of site-reported device
and/or procedure related serious adverse events (SAEs)
observed through 24 months among pivotal subjects
(by MedDRA Code).
Table 8. Summary of SAEs through 24 Months
(Site Reported) (Pivotal Analysis Set)
Device-Related
1
System Organ Class /
Subjects
Events
Preferred Term
% (n/N)
N
Total Patients with
2.9% (11/384)
11
Serious Adverse Events
Blood and lymphatic
0.0% (0/384)
0
system disorders
Haemorrhagic anaemia
0.0% (0/384)
0
Cardiac disorders
2.1% (8/384)
8
Coronary artery dissection 0.8% (3/384)
3
Myocardial infarction
0.5% (2/384)
2
Arrhythmia
0.0% (0/384)
0
Angina pectoris
0.3% (1/384)
1
Cardiac arrest
0.0% (0/384)
0
Cardiac failure congestive
0.0% (0/384)
0
Coronary artery disease
0.0% (0/384)
0
Coronary artery occlusion
0.0% (0/384)
0
Coronary artery
0.3% (1/384)
1
perforation
Coronary artery stenosis
0.0% (0/384)
0
Coronary artery
0.0% (0/384)
0
thrombosis
Left ventricular failure
0.0% (0/384)
0
Myocardial ischaemia
0.3% (1/384)
1
Congenital, familial and
0.0% (0/384)
0
genetic disorders
Congenital coronary
0.0% (0/384)
0
artery malformation
General disorders and
0.0% (0/384)
0
administration site
conditions
Pain
0.0% (0/384)
0
Hepatobiliary disorders
0.0% (0/384)
0
Hepatic failure
0.0% (0/384)
0
Injury, poisoning and
0.5% (2/384)
2
procedural complications
Vascular access site
0.0% (0/384)
0
haematoma
Coronary artery restenosis 0.5% (2/384)
2
Investigations
0.0% (0/384)
0
Myocardial necrosis
0.0% (0/384)
0
marker increased
(elevated cardiac
biomarker)
Nervous system disorders 0.0% (0/384)
0
Cerebrovascular accident
0.0% (0/384)
0
Dizziness
0.0% (0/384)
0
Seizure
0.0% (0/384)
0
N (%)
Procedure-Related
2
Subjects
Events
% (n/N)
N
8.1% (31/384)
44
0.3% (1/384)
1
0.3% (1/384)
1
6.0% (23/384)
27
2.9% (11/384)
11
2.1% (8/384)
8
0.5% (2/384)
2
0.5% (2/384)
2
0.0% (0/384)
0
0.0% (0/384)
0
0.0% (0/384)
0
0.0% (0/384)
0
0.3% (1/384)
1
0.0% (0/384)
0
0.3% (1/384)
1
0.0% (0/384)
0
0.3% (1/384)
1
0.3% (1/384)
1
0.3% (1/384)
1
0.0% (0/384)
0
0.0% (0/384)
0
0.3% (1/384)
1
0.3% (1/384)
1
1.0% (4/384)
4
0.3% (1/384)
1
0.8% (3/384)
3
0.5% (2/384)
2
0.5% (2/384)
2
0.3% (1/384)
1
0.3% (1/384)
1
0.0% (0/384)
0
0.0% (0/384)
0
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