CLINICAL TRIAL PROTOCOL SPACE 2 Stent ... - SPACE-2 Studie
CLINICAL TRIAL PROTOCOL SPACE 2 Stent ... - SPACE-2 Studie
CLINICAL TRIAL PROTOCOL SPACE 2 Stent ... - SPACE-2 Studie
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Clinical Trial Code: <strong>SPACE</strong> 2 Version: 10. October 2008 Final<br />
Screening<br />
Randomization<br />
CAS/CEA<br />
Informed consent X X<br />
Ultrasound X X X X X X X X X<br />
ECG X X<br />
Risk factor screening using a X X X X X X X X X<br />
standardized questionnaire<br />
Modified Rankin Score X a a a a a a a a<br />
NIH Stroke Scale X a a a a a a a a<br />
Co-medication X X X X X X X X X<br />
Event-Screening: X X X X X X X X X<br />
• Any stroke X X X X X<br />
• Ipsilateral ischemic stroke X X X X X X X X<br />
• Death from any cause X X X X<br />
• Vascular death X X X X<br />
• Myocardial infarction X<br />
• Technical failure X<br />
Adverse Events X X X X X X X X X<br />
a: only in case of outcome events; b: only if randomized to CEA or CAS<br />
_______________________________________________________________________________________________________<br />
D1 b<br />
Page 9 of 49<br />
D30<br />
M6<br />
A1<br />
A2<br />
A3<br />
A4<br />
A5
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