Excite In-Stent Restenosis (Isr) Study - Spectranetics Turbo-Power Gebrauchsanweisung

Table 7.1.2 Target Lesion Characteristics: Angiographic Core Lab Assessment (per lesion)
Procedural Angiographic Core Lab CRF
Number of Lesions per Patient Number of Lesions per Patient
-- 0*
-- 1
-- 2
-- 3
BASELINE LESION MORPHOLOGY
Stenosis Length (mm)
Diameter Stenosis (%)
MLD
Reference vessel diameter (mm)
Lesion Location Within Limb
-- Isolated SFA
-- Isolated Popliteal
-- SFA - Popliteal
-- BTK
-- ATK & BTK
Distal Runo :
-- Absent
-- 1 Vessel
-- 2 or more Vessels
-- N/A
MORPHOLOGY
Type of Lesion: Type of Lesion:
-- Stenosis
-- Occlusion
Thrombus Present
-- Absent
Eccentric Lesion:
-- Concentric
-- Eccentric
Aneurysm Present: Aneurysm Present:
-- Absent
Ulcerated Plaque Present: Ulcerated Plaque Present:
-- Absent
-- Present
Calci cation category: Calci cation category:
-- None/Mild
-- Moderate
-- Severe
Table 7.1.3 Primary Safety Endpoint
Freedom from MAE
Table 7.1.4 Primary E ectiveness Endpoint - Mean Percentage Reduction in Percent Diameter Stenosis post Turbo-Elite
Reduction in %DS
7.2

EXCiTE In-Stent Restenosis (ISR) Study

Purpose: This trial evaluated the safety and e ectiveness of Excimer Laser Atherectomy (ELA) using the Spectranetics Turbo-Elite™ Laser Ablation
Catheter to create a pilot channel for lesion treatment using the Spectranetics Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
with adjunctive percutaneous transluminal angioplasty (PTA) in comparison with PTA alone in the treatment of femoropopliteal bare nitinol in-stent
restenosis in vessels ≥5mm.
Methods: This trial was a prospective randomized controlled trial performed respectively in a 2:1 randomization scheme. The primary e ectiveness
measure was patency, de ned as achievement of Procedural Success in the Index Procedure and Freedom from Clinically Driven TLR through 6 months
follow-up. The primary safety endpoint was de ned as Freedom from Major Adverse Events (MAE) at 30 days. MAE are de ned all-cause death,
major amputation in the target limb, or target lesion revascularization (TLR) (surgical or interventional) from procedure to 30 days (±7 days). Patients were
treated using the Turbo-Tandem™ Laser Catheter and, if a 2mm pilot channel did not exist prior to treatment, a Turbo-Elite™ laser catheter was used to
create a pilot channel as an accessory to Turbo-Tandem™.
Description of Patients: Two hundred and fty (250) patients were prospectively enrolled at a total of 40 US centers. Comparing ELA+PTA to PTA,
patients were predominantly male (63% vs. 62%), and elderly (age: 69±10 vs. 68±10 yr.). The most common comorbidities/risk factors were hypertension
(96% vs. 94%), hyperlipidemia (96% vs. 95%), and smoking history (85% vs. 91%). Baseline lesion characteristics assessed by the sites were generally
comparable between groups. Mean lesion length was 17±12 vs. 16±11 cm, reference vessel diameter was 5.6±0.5 vs. 5.6±0.6 mm, and stenosis diameter
was 88±13 vs. 88±14%.
Results: The primary safety endpoint of this study was met. The primary safety hypothesis was that the rate of major adverse events (MAE) through
30 days with ELA+PTA, which included all-cause death, major amputation in the target limb, or target lesion revascularization (TLR), would be non-inferior
to PTA. The 30-day MAE rates were 5.8% for ELA+PTA and 20.5% for PTA. The probability that ELA+PTA was non-inferior to PTA was >0.9999, which was
greater than the 0.9975 required for early success. Additionally, the probability that ELA+PTA was superior to PTA was 0.9999, which was also greater than
the 0.9975 required for early success.
The primary e ectiveness endpoint of this study was also met. The primary e ectiveness hypothesis was that freedom from TLR through 6 months with
ELA+PTA would be superior to PTA. Freedom from TLR through 6 months was 73.5% for ELA+PTA and 51.8% for PTA. The probability that ELA+PTA was
superior was 0.9994, which was greater than the 0.9975 required for early success.
Table 7.2.1 Baseline Patient Characteristics
Screening Clinical
Assessment CRF
Patients
Gender (% male)
Age at Screening (years) Age at Screening (years)
Weight (kg)
Height (cm)
History of Hypertension History of Hypertension
History of Hyperlipidemia History of Hyperlipidemia
History of Diabetes Mellitus History of Diabetes Mellitus
-- Insulin Dependent
History of CAD History of CAD
History of CVA History of CVA
Smoking Status:
-- Never
P015612-03 13APR21 (2021-04-13)
Turbo-Power™ Laser Atherectomy Catheter
Mean ± SD (N) (Min, Median, Max) or n/N (%)
# (%) of Patients
1/43 (2.3%)
33/43 (76.7%)
8/43 (18.6%)
1/43 (2.3%)
94.7 ± 73.0 (45) (9, 76.1, 270)
80.0 ± 16.5 (52) (50, 78.3, 100)
0.9 ± 0.8 (52) (0, 0.8, 3)
4.7 ± 1.2 (52) (1.6, 5.0, 6.6)
32/52 (61.5%)
5/52 (9.6%)
2/52 (3.8%)
12/52 (23.1%)
1/52 (1.9%)
2/52 (3.8%)
17/52 (32.7%)
27/52 (51.9%)
6/52 (11.5%)
35/52 (67.3%)
17/52 (32.7%)
52/52 (100.0%)
51/52 (98.1%)
1/52 (1.9%)
52/52 (100.0%)
51/52 (98.1%)
1/52 (1.9%)
36/51 (70.6%)
11/51 (21.6%)
4/51 (7.8%)
n/N (%) N=43
38/39 (97.4%)
Mean ± SE
45.0% ± 2.4%
Mean ± SD (N) (Min, Median, Max) or n/N (%)
Excimer Laser Atherectomy
PTA Alone
+ PTA
169 81
106/169 (62.7 %) 50/81 (61.7 %)
68.5±9.8 (n=169) 67.8±10.3 (n=81)
82.2±18.9 (n=168) 80.4±16.4 (n=80)
170.0±10.4 (n=168) 168.7±9.7 (n=80)
161/168 (95.8 %) 75/80 (93.8 %)
162/168 (96.4 %) 76/80 (95.0 %)
79/168 (47.0 %) 38/80 (47.5 %)
34/79 (43.0 %) 17/38 (44.7 %)
108/168 (64.3 %) 55/80 (68.8 %)
18/168 (10.7 %) 5/80 (6.3 %)
25/167 (15.0 %) 7/80 (8.8 %)
Screening Clinical
Assessment CRF
-- Current
-- Stopped
Lesion Location: Within Limb:
-- Isolated SFA
-- Isolated Popliteal
-- SFA-Popliteal
% Diameter Stenosis
Total lesion Length (mm)
Reference Vessel Diameter (mm)
Length of Extra Stent Lesion (mm)
Subjects without extra stent lesion present
Stent Fracture Present:
-- Grade 0
-- Grade 1
-- Grade 2
-- Grade 3
Target Lesion Thrombus
Target Lesion Aneurysm Target Lesion Aneurysm
Target lesion Calci cation: Target lesion Calci cation:
-- None
-- Mild
-- Moderate
-- Severe
Anterior Tibial Stenosis:
-- <= 50% (Patent)
-- >50% (Stenosed)
-- Occluded
Posterior Tibial Stenosis:
-- <= 50% (Patent)
-- >50% (Stenosed)
-- Occluded
Peroneal Stenosis:
-- <= 50% (Patent)
-- >50% (Stenosed)
-- Occluded
Table 7.2.2 Post PTA Procedural Outcomes
Procedural Angiographic Core Lab CRF
Target Lesion Residual Stenosis post PTA procedure
(%)
Target Vessel Dissection post PTA:
-- Yes
-- No
-- Not Assessed
Dissection Grade Upon Visual Assessment post PTA:
-- A
-- B
-- C
-- D
-- F
Table 7.2.3 Primary Safety Endpoint
Freedom from TLR ELA + PTA
a
Intent-To-Treat 86/117 (73.5%)
Per Protocol 78/100 (78.0%)
As Treated c 88/121 (72.7%)
a Freedom from any MAE de ned as TLR, death or amputation through 37 days post procedure
b Chi-square
c As treated consisted of four subjects randomized to PTA alone that received provisional laser treatment after PTA treatment failure. Two of these subjects
also underwent bailout stenting. These four subjects were assigned to ELA + PTA for the purposes of this analysis.
Table 7.2.4 Primary E ectiveness Endpoint
ELA + PTA
Freedom from TLR a
Intent-To-Treat 86/117 (73.5%)
Per Protocol 78/100 (78.0%)
As Treated c 88/121 (72.7%)
a Freedom from TLR through 212 days post procedure
Chi-square
b
As treated consisted of four subjects randomized to PTA alone that received provisional laser treatment after PTA treatment failure. Two of these subjects
c
also underwent bailout stenting. These four subjects were assigned to ELA + PTA for the purposes of this analysis.
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Intent to Treat Analysis: The intent-to-treat patient (ITT) population included all randomized patients who underwent treatment with ELA-PTA or PTA.
Per Protocol Analysis: The per-protocol (PP) population (AT) included all patients who underwent treatment with ELA-PTA or PTA and had no inclusion /
exclusion violations or device use that was not allowed (e.g. scoring balloon).
As Treated Analysis: The as treated (AT) analysis re ects the actual treatment received, regardless of randomization assignment.
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Mean ± SD (N) (Min, Median, Max) or n/N (%)
Excimer Laser Atherectomy
PTA Alone
+ PTA
50/167 (29.9 %) 36/80 (45.0 %)
92/167 (55.1 %) 37/80 (46.3 %)
137/169 (81.1 %) 72/81 (88.9 %)
3/169 (1.8 %) 4/81 (4.9 %)
29/169 (17.2 %) 5/81 (6.2 %)
87.6±12.6 (n=168) 87.8±13.7 (n=81)
(50.0, 90.0, 100.0) (50.0, 90.0, 100.0)
173.4±117.8 (n=169) 163.6±106.7 (n=81)
(30.0, 140.0, 550.0) (5.0, 140.0, 430.0)
5.6±0.5 (n=168) 5.6±0.6 (n=80)
(5.0, 6.0, 7.0) (5.0, 5.8, 7.0)
15.5±12.3 (n=60) 20.1±14.6 (n=26)
(1.0, 10.0, 70.0) (2.5, 20.0, 64.0)
109/169 (64.5 %) 55/81 (67.9 %)
146/169 (86.4 %) 72/81 (88.9 %)
11/169 (6.5 %) 5/81 (6.2 %)
6/169 (3.6 %) 3/81 (3.7 %)
6/169 (3.6 %) 1/81 (1.2 %)
11/169 (6.5 %) 4/81 (4.9 %)
0/169 (0.0 %) 0/81 (0.0 %)
72/169 (42.6 %) 41/81 (50.6 %)
62/169 (36.7 %) 26/81 (32.1 %)
25/169 (14.8 %) 7/81 (8.6 %)
10/169 (5.9 %) 7/81 (8.6 %)
102/168 (60.7 %) 56/81 (69.1 %)
25/168 (14.9 %) 11/81 (13.6 %)
41/168 (24.4 %) 14/81 (17.3 %)
100/168 (59.5 %) 54/81 (66.7 %)
21/168 (12.5 %) 10/81 (12.3 %)
47/168 (28.0 %) 17/81 (21.0 %)
117/168 (69.6 %) 62/81 (76.5 %)
21/168 (12.5 %) 8/81 (9.9 %)
30/168 (17.9 %) 11/81 (13.6 %)
Mean ± SD (N) (Min, Median, Max) or n/N (%)
Excimer Laser
PTA Alone
Atherectomy + PTA Atherectomy + PTA Atherectomy + PTA
11.5±13.5 (n=165) 18.1±18.2 (n=81)
15/169 (8.9 %) 15/81 (18.5 %)
148/169 (87.6 %) 66/81 (81.5 %)
6/169 (3.6 %) 0/81 (0.0 %)
7/15 (46.7 %) 9/15 (60.0 %)
7/15 (46.7 %) 0/15 (0.0 %)
1/15 (6.7 %) 4/15 (26.7 %)
0/15 (0.0 %) 1/15 (6.7 %)
0/15 (0.0 %) 1/15 (6.7 %)
1
PTA Only P-value
b
29/56 (51.8%) 0.0046
21/45 (46.7%) 0.0002
29/52 (55.8%) 0.0288
PTA Only
P-value b
29/56 (51.8%) 0.0046
21/45 (46.7%) 0.0002
29/52 (55.8%) 0.0288
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