Parent Artery Reconstruction for Large or Giant Cerebral Aneurysms Using the Tubridge Flow Diverter: A Multicenter, Randomized, Controlled Clinical Trial (PARAT)

Article Figures & Data

Table 1:

Structural comparison between different FDs

FD Type	Size	Braided Microfilaments^{^a}		Radiopaque Microfilaments	Flared End	Metal Coverage	Retrievable
FD Type	Size	No.	Material	Radiopaque Microfilaments	Flared End	Metal Coverage	Retrievable
Pipeline	3–5.5 mm	48	75% cobalt chromium and 25% platinum	NA	No	30%–35%	Yes^{^b}
Silk	2.5–5 mm	48	Nickel-titanium alloy	4 Platinum wires	Yes	35%–55%	Yes
Surpass	2.5–5 mm	2.5 mm (36)	Cobalt-chromium	12 Platinum wires	No	30%	NA
		3 and 4 mm (60)
		5 mm (84)
FRED	2.5–5.5 mm	Inner layer (48)	Nickel-titanium alloy	2 Tantalum wires	Yes	NA	Yes
FRED	2.5–5.5 mm	Outer layer (16)	Nickel-titanium alloy	2 Tantalum wires	Yes	NA	Yes
Tubridge	2.5–6.5 mm	<3.5 mm (46)	Nickel-titanium alloy	2 Platinum-iridium wires	Yes	30%–35%	Yes
Tubridge	2.5–6.5 mm	≥3.5 mm (62)	Nickel-titanium alloy	2 Platinum-iridium wires	Yes	30%–35%	Yes

Note:—NA indicates not applicable.
↵a Braided microfilaments in this table mean those main wires excluding microfilaments especially for radiopaque usage.
↵b Pipeline Flex embolization devices are retrievable.

Table 2:

Baseline characteristics of the full analysis set^{^a}

Characteristics	Tubridge Group n = 82	Enterprise Group n = 62
Mean age (yr)	52.11 (10.31)	55.66 (9.53)
Sex ratio (male/female)	21:61	13:49
Medical history
Cerebrovascular stroke	9 (10.98%)	8 (12.90%)
Coronary artery disease	1 (1.22%)	4 (6.45%)
Hypertension	41 (50.0%)	25 (40.32%)
Hypercholesterolemia	4 (4.88%)	3 (4.84%)
Diabetes	5 (6.10%)	2 (3.23%)
Current/previous smoking	12 (14.63%)	7 (11.29%)
Systolic blood pressure (median) (mm Hg)	129.50 (120.0–143.0)	129.50 (120.0–138.0)
Aneurysm location^{^b}
Anterior circulation	77 (96.25%)	59 (98.33%)
Posterior circulation	3 (3.75%)	1 (1.67%)
Aneurysm size (median)	18.00 (13.14–26.0)	17.14 (12.44–24.74)
Aneurysm size classification
Large (10–15 mm)	30 (36.59%)	24 (38.71%)
Very large or giant (>15 mm)	52 (63.41%)	38 (61.29%)

↵a Data are No. (%), median (interquartile range), or mean (SD).
↵b Of the 6 patients with failed procedures, locations of 2 aneurysms were absent.

Table 3:

Sensitivity analyses on the composite primary outcome

Factoring in Subjects Who Missed F/U	6-Mo Occlusion Rate		Unadjusted Result			Adjusted Result^{^a}
Factoring in Subjects Who Missed F/U	Tubridge Group	Control Group	OR	95% CI	P Value	OR	95% CI	P Value
Missing F/U excluded (PPS)	55/73, 75.34%	13/53, 24.53%	9.40	4.14–21.38	<.001	9.31	4.00–21.66	<.001
Missing F/U counted as complete occlusion	64/82, 78.05%	22/62, 35.48%	6.47	3.09–13.52	<.001	6.14	2.92–12.91	<.001
Missing F/U counted as not completely occluded	55/82, 67.07%	13/62, 20.97%	7.68	3.57–16.51	<.001	7.34	3.36–16.05	<.001
Missing F/U counted as complete occlusion for control and incomplete occlusion for Tubridge	55/82, 67.07%	22/62, 35.48%	3.70	1.85–7.42	<.001	3.49	1.73–7.03	<.001

Table 4:

Data correlating aneurysm location and size with aneurysm complete occlusion rate

Aneurysm Location	No.	Aneurysm Size (mm)	Proportion of Giant Aneurysms	100% Occlusion Rate at 6-Mo F/U
Aneurysm Location	No.	Aneurysm Size (mm)	Proportion of Giant Aneurysms	Tubridge	Controls
ICA communicating	19	18.0 ± 7.6 (10.0–33.9)	4/19	76.9%, 10/13	40%, 2/5
ICA ophthalmic	39	15.8 ± 5.6 (10.0–30.0)	4/39	83.3%, 15/18	33.3%, 6/18
ICA paraclinoid or cavernous	73	21.8 ± 7.5 (10.0–45)	25/73	75.7%, 28/37	13.8%, 4/29
ICA petrous	3	21.3 ± 9.3 (15.0–32.0)	1/3	50%, 1/2	0
Vertebral artery	4	14.3 ± 2.2 (12.0–16.3)	0/4	33.3%, 1/3	100%, 1/1

Table 5:

Secondary outcome evaluation

Secondary Outcome	Enterprise n = 62	Tubridge n = 82	Odds Ratio (95% CI)	P Value
Immediate technique success rate	59/62 (95.16%)	79/82 (96.34%)	1.34 (0.26–6.87)	.726
Death or target vessel–related stroke
30 days	7/62 (11.29%)	11/82 (13.41%)	0.821 (0.299–2.258)	.703
90 days	8/62 (12.90%)	12/82 (14.63%)	0.864 (0.330–2.263)	.766
1 yr	9/62 (14.52%)	14/82 (17.07%)	0.825 (0.332–2.051)	.678
Mortality rate
30 days	1/62 (1.61%)	3/82 (3.66%)	0.432 (0.044–4.253)	.634
90 days	1/62 (1.61%)	4/82 (4.88%)	0.320 (0.035–2.934)	.391
1 yr^{^a}	2/62 (3.23%)	4/82 (4.88%)	0.650 (0.115–3.668)	.699
Hemorrhagic stroke related to target vessel
30 days	2/62 (3.23%)	5/82 (6.1%)	0.531 (0.096–2.738)	.699
90 days	2/62 (3.23%)	5/82 (6.1%)	0.531 (0.096–2.738)	.699
1 yr	2/62 (3.23%)	5/82 (6.1%)	0.531 (0.096–2.738)	.699
Ischemic stroke related to target vessel
30 days	4/62 (6.54%)	6/82 (7.32%)	0.874 (0.236–3.239)	.874
90 days	5/62 (8.06%)	6/82 (7.32%)	1.111 (0.323–3.822)	.867
1 yr	6/62 (9.68%)	8/82 (9.76%)	0.991 (0.325–3.109)	.987
Aneurysm rupture
30 days	1/62 (1.61%)	3/82 (3.66%)	0.357 (0.072–1.783)	.634
90 days	1/62 (1.61%)	3/82 (3.66%)	0.357 (0.072–1.783)	.634
1 yr	1/62 (1.61%)	3/82 (3.66%)	0.357 (0.072–1.783)	.634
General adverse events
30 days	26/62 (41.94%)	42/82 (51.22%)	0.808 (0.293–2.229)	.269
90 days	26/62 (41.94%)	42/82 (51.22%)	0.808 (0.293–2.229)	.269
1 year	33/62 (53.23%)	46/82 (56.10%)	0.938 (0.644–1.365)	.88
Rate of intrastent stenosis	2/53 (3.77%)	4/73 (5.48%)	0.676 (0.119–3.837)	1
Rate of intrastent thrombosis	1/59 (1.69%)	6/79 (7.59%)	0.215 (0.025–1.839)	.273