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

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Clinical Trial Code: SPACE 2 Version: 10. October 2008 Final ABBREVIATIONS AE Adverse Event BDSG Bundesdatenschutzgesetz BMBF Bundesministerium für Bildung und Forschung BMT Best medical treatment CAS Carotid artery stenting CEA Carotid endarterectomy CRF Case Report Form CTCAE Common Toxicity Criteria for Adverse Events CV Curriculum Vitae DBL Data Base Lock DFG Deutsche Forschungsgemeinschaft DMC Data Monitoring Committee DVP Data Validation Plan EC Ethics Committee EEC Endpoint Evaluation Committee ExC Executive Committee ECG Electrocardiogram GCP Good Clinical Practice ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ISF Investigator Site File ISRCTN International Standard Randomized Controlled Trial Number ITT Intention To Treat KKS Coordination Center for Clinical Trials (Koordinierungszentrum für Klinische Studien) LKP Coordinating Investigator according to German law (Leiter der Klinischen Prüfung) n.a. not applicable OE Outcome Event SAE Serious Adverse Event SC Steering Committee SDV Source Data Verification SUSAR Suspected Unexpected Serious Adverse Reaction TMF Trial Master File _______________________________________________________________________________________________________ Page 4 of 49
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 _______________________________________________________________________________________________________ Page 5 of 49
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