CLINICAL TRIAL PROTOCOL SPACE 2 Stent ... - SPACE-2 Studie

Clinical Trial Code: SPACE 2 Version: 10. October 2008 Final
TABLE OF CONTENTS
Clinical Trial Protocol Summary 2
Abbreviations 4
Table of Contents 5
Flow Chart / Trial Schedule 8
1 Introduction 10
1.1 Scientific background 10
1.1.1 Evidence 11
1.1.2 Role of conservative treatment 11
1.1.3 Role of carotid endarterectomy 11
1.1.4 Role of carotid artery stenting 12
1.2 Trial rationale/ justification 12
1.3 Benefit / risk assessment 13
2 Trial Objectives and Endpoints 13
2.1 General aim / primary objective 13
2.2 Assessment of safety 14
2.3 Composite primary efficacy endpoint 14
2.4 Secondary and tertiary outcomes 14
3 Trial Design 14
4 Selection of Subjects 15
4.1 Number of subjects 15
4.2 General criteria for subjects’ selection 15
4.3 Inclusion criteria 15
4.4 Exclusion criteria 16
4.5 Criteria for withdrawal 16
4.5.1 Withdrawal of subjects 16
4.5.2 Replacement of Subjects 17
4.5.3 Premature Closure of the Clinical Trial 17
4.6 Prior and concomitant illnesses 18
4.7 Prior and concomitant treatments 18
5 Trial Procedures 18
5.1 Description of trial days 18
5.2 Screening and randomization 19
5.2.1 Informed consent 19
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