Specifications

© 2011 Cardiovascular Systems, Inc. 5 90168-00.K
Clinical Summary
The prospective multi-center Clinical Study of the O
rbital Atherectomy System for the Treatment of Peripheral
Vascular Stenosis [OASIS] was conducted to evaluate the safety and effectiveness of Orbital Atherectomy in patients
with symptomatic PAD. 124 patients from 17 contributing centers were enrolled, and 201 lesions were treated with
OA. Primary safety and efficacy endpoints (major clinical events at 30 days and acute debulking, respectively) were
compared with pre-specified objective performance criteria (OPC). Non-inferiority to both primary endpoints was
demonstrated (p < 0.05). The number of patients who met the primary efficacy objective using only the
investigational device was 91/124 or 73.4%. The number of lesions in which the primary efficacy objective was met
using only the investigational device was 125/201 or 62.2%.
A summary of the Safety and Effectiveness is provided
in the following table:
OASIS: Summary of Safety and Effectiveness* (n= 124 patients, 201 lesions)
Parameter Result
Baseline information:
Age, mean
% male
ABI, mean
Reference vessel diameter
Target lesion length
70.4 +
9.97 years
66.9 %
0.68 +
0.2
3.2 +
0.7 mm
29.8 + 26.5 mm
Primary efficacy endpoint- mean decrease in diameter stenosis
Baseline %DS
Post- OA %DS
Mean decrease
86.8 +
11.8 %
25.5 +
20.8 %
61.7 + 23.4 % OPC = 55%
Primary safety endpoint- number (%) of patients with at least 1
major complication within 30 days
(
n=124 patients with 30 day follow-up)
Death
Acute MI
Major bleeding requiring surgery
Major vascular complication requiring surgery
Aneurysm or false aneurysm at insertion site
Amputation, major
Perforation
Abrupt, or acute vessel closure requiring surgery
Major dissection
Distal embolization
Thrombus formation at treatment site
TVR/TLR through 30 days
At least 1 major adverse event
ABI- 30 days, mean
2/124 (1.6%)
1/124 (0.8%)
0/124 (0)
0/124 (0)
4/124 (3.2%)
0/124 (0)
2/124 (1.6%)
1/124 (0.8%)
0/124 (0)
1/124 (0.8%)
1/124 (0.8%)
0
10/124 (8.1%)
0.9 ± 0.18 OPC = 8%
OA treatment time, mean 183.1 +/- 108.2 sec
* Abbreviations: ABI= ankle brachial index; DS= diameter stenosis; OA= orbital atherectomy; OPC= objective
performance criteria; MI= myocardial infarction; TVR/TLR- target vessel/lesion revascularization