3
The effectiveness of the Angio-Seal Device was evaluated by times to hemostasis and ambulation. Time to hemostasis was de
fi
ned as the elapsed time from device deployment
until cessation of bleeding. Time to ambulation was de
fi
ned as the elapsed time from device deployment to the time the patient walked for
fi
ve minutes or 100 feet. Major and overall
complication rates comprised the safety endpoints. A major complication was de
fi
ned as surgical vascular repair; bleeding requiring transfusion; infection extending hospitalization; and
pseudoaneurysm, AV
fi
stula, deep vein thrombosis, or retroperitoneal bleeding that required treatment by surgical intervention or ultrasound guided compression. Data were analyzed
separately in diagnostic, 8F interventional, and 6F interventional arms.
Effectiveness Results
The results of the effectiveness measures are summarized in Tables 2 and 3.
Table 2: Time to Hemostasis
Time to Hemostasis
(minutes)
Diagnostic
Patients (n = 97)
8F Interventional
Patients (n = 105)*
6F Interventional
Patients (n = 103)
Mean ± SD
Range
0.3 ± 1.3
0-10
7.2 ± 35.5
0-240
18.7 ± 70.3
0-520
Distribution
t = 0
t
≤
1
t
≤
2
t
≤
5
t
≤
10
t > 10
Cumulative N (%)
89 (92%)
91 (94%)
92 (95%)
96 (99%)
97 (100%)
97 (100%)
Cumulative N (%)
84 (80%)
92 (88%)
94 (90%)
95 (90%)
99 (94%)
105 (100%)
Cumulative N (%)
70 (68%)
73 (71%)
77 (75%)
85 (82%)
90 (87%)
103 (100%)
* In one patient, the physician lost access. No time to hemostasis was recorded.
Table 3: Time to Ambulation
Time to Ambulation
(hours)
Diagnostic
(n = 92)
8F Interventional
(n = 98)
6F Interventional
(n = 99)
Mean ± SD
Range
0.1 ± .09
0-4.4
6.2 ± 7.3
0.2-48.0
6.1 ± 6.6
1.9-43.0
Distribution*
t
≤
0.25
t
≤
0.5
t
≤
1
t
≤
2
t
≤
3
t
≤
4
t
≤
5
t > 5
Cumulative N (%)
14 (15%)
28 (30%)
51 (55%)
77 (84%)
88 (96%)
91 (99%)
92 (100%)
92 (100%)
Cumulative N (%)
1 (1%)
1 (1%)
3 (3%)
10 (10%)
36 (37%)
53 (54%)
73 (74%)
98 (100%)
Cumulative N (%)
0 (0%)
0 (0%)
0 (0%)
10 (10%)
35 (35%)
57 (58%)
68 (69%)
99 (100%)
* Time to ambulation varied across investigational centers and may have been a result of variable clinical approaches taken by physicians when ambulating patients.
Early Ambulation and Discharge Study in 6F Diagnostic Patients
In a clinical study to evaluate safety and ef
fi
cacy of early ambulation and discharge, the Angio-Seal STS device was clinically evaluated in patients who had undergone diagnostic
angioplasty procedures using a 6 French or smaller procedural sheath. The Angio-Seal STS was evaluated for safety and ef
fi
cacy when ambulating patients as soon as possible
following device deployment and discharging patients as early as 30 minutes following ambulation.
Methods:
Patients who met all inclusion and no exclusion criteria were enrolled during a pre-procedure screening evaluation. Four U.S. investigational centers participated in the study. The primary
endpoints studies were 1) rate of major complication, 2) time to ambulation and 3) time to discharge.
Results:
A total of 132 patients (75% male: mean age 61.89 years) received the 6F Angio-Seal STS device from March 14, 2002 through September 6, 2002 after diagnostic angiography and
were included in analyses of study endpoints. The evaluation of time to ambulation and time to discharge were relative to the time of deployment being de
fi
ned as time “zero.” The
median time to ambulation from device deployment was 9.00 minutes (mean 18.95 +/- 30.7 minutes) and the median time to discharge from deployment was 70.00 minutes (mean 78.65
+/- 32.54). Hypothesis testing on the median yielded a p-value of < 0.001 for time to ambulation and < 0.001 for time to discharge, supporting the study hypothesis that the median time
to ambulation is less than one hour and the median time to discharge is less than three hours. If the time of discharge is evaluated relative to the time of ambulation, with the time of
ambulation de
fi
ned as time “zero,” the median time to discharge is 60 minutes (mean 59.91 +/- 15.87 minutes).
No “Major” complications were reported for the study patients, with only one “Minor” complication noted. Hypothesis testing yielded a p-value of 0.005, supporting the conclusion that the
major complication rate is less than 5%.
Table 4: Results of Early Ambulation and Discharge Study
Endpoint
Study Patients
Time to ambulation
(minutes post deployment)
Mean ± Std. Dev. (95% C.I.)
Median (95% C.I.)
Range
(N)
18.95 ± 30.71 (13.64, 24.26)
9.00 (7, 15)
1 to 323
(131)
Time to discharge
(minutes post deployment)
Mean ± Std. Dev. (95% C.I.)
Median (95% C.I.)
Range
(N)
78.65 ± 32.54 (73.01, 84.30)
70.00 (67, 75)
38 to 368
(130)
Time to discharge
(minutes post deployment)
Mean ± Std. Dev. (95% C.I.)
Median (95% C.I.)
Range
(N)
59.91 ± 15.87 (57.15, 62.66)
60.00
20 to 120
(130)
Endpoint
Study Patients
Major complications (N)
0 (n=125)
z-statistic; p-value
2.56; 0.005
Minor complications
1
