1 Version June 06, 2017 MR CLEAN R study protocol. Protocol for the MR CLEAN- registry (MR CLEAN-R). A multicenter registry of endovascular treatment for acute ischemic stroke Authors: 1 2 3 2 1 2. Ivo Jansen , Maxim Mulder , Robert-Jan Goldhoorn , Kars Compagne , Olvert Berkhemer , Puck Fransen , 3 1 4 5 1 1. Debbie Beumer , Lucie van den Berg , Jelis Boiten , Jan-Albert Vos , Charles Majoie , Yvo Roos , Robert 3 3 2 2. van Oostenbrugge , Wim van Zwam , Aad van der Lugt and Diederik Dippel 1. Academic Medical Center Amsterdam, departments of neurology and radiology 2.
2 Erasmus MC University Medical Center Rotterdam, departments of neurology and radiology 3. Maastricht University Medical Center, departments of neurology and radiology 4. Haaglanden Medical Center, department of neurology 5. St. Antonius Hospital, department of radiology 1. Version June 06, 2017 MR CLEAN R study protocol. CONTENTS. Acknowledgments .. 3. Summary .. 4. 1. Introduction and rationale .. 6. 2. Objectives .. 6. 3. Study Design .. 7. 4. Study Population .. 7. 5. treatment of 8. 6. Methods .. 10. 7. Safety Reporting.
3 11. 8. Statistical analyses .. 12. 9. Ethical considerations, access to appropriate treatment .. 10. 10. Administrative aspects and publication .. 13. 11. References .. 14. 12. 17. 13. Appendices .. 18. 2. Version June 06, 2017 MR CLEAN R study protocol. ACKNOWLEDGMENTS. The study is designed, and will be conducted, analyzed and interpreted by the investigators independently of all sponsors. 3. Version June 06, 2017 MR CLEAN R study protocol. SUMMARY. RATIONALE AND AIM. After the last inclusion in the MR CLEAN trial there is a momentum in endovascular treatment (EVT) for acute anterior circulation ischemic stroke in the Netherlands.
4 The international guidelines and recommendations allowed endovascular treatment as a rescue treatment , but since early 2015,abundant proof of a beneficial effect of endovascular treatment on functional outcome has become available. The purpose of the MR CLEAN-R is a post-trial registry of the multicenter Randomized Clinical trial of Intra-arterial treatment for acute ischemic stroke in the Netherlands is to monitor implementation and safety of the new endovascular treatment . MR CLEAN-R is a multicenter registry . In the period following the last inclusion of the MR CLEAN trial this study will register all patients with acute ischemic stroke caused by intracranial occlusion who undergo endovascular treatment .
5 STUDY POPULATION. All patients undergoing endovascular treatment for acute ischemic stroke will be registered. The core study population, however, will consist of patients with a clinical diagnosis of acute ischemic stroke due to a proximal arterial occlusion in the anterior cerebral circulation demonstrated by neuro-imaging and endovascular treatment started within hours after stroke onset. Intracerebral hemorrhage should be ruled out by CT or MRI. INTERVENTION. endovascular treatment may consist of intra-arterial thrombolysis with urokinase or alteplase, mechanical treatment or both.
6 Mechanical treatment refers to retraction or aspiration of the thrombus with a catheter guided device, including use of a retrievable stent. The exact choice of endovascular treatment modality for each patient is left to the discretion of the local investigator and treating physicians. Medical management will be delivered according to national standards and guidelines. It may include treatment with intravenous alteplase before inclusion in the registry . MAIN OUTCOME MEASURES. The primary outcome is the score on the modified Rankin Scale (mRS) 90 days after inclusion in the study.
7 This categorical scale measures the functional outcome. Secondary clinical measures are the National Institutes of Health Stroke Scale (NIHSS) score pre- and post (<48 hours) treatment and time points of onset, groin puncture and first substantial reperfusion. Secondary imaging-based measurements are pre- and posttreatment collateral status on DSA (TICI), infarct volume on CT and evaluation of the carotid arteries with respect to atherosclerotic disease on CT angiography (CTA). Safety parameters include intra- and extracranial hemorrhagic complications, neurological deterioration, arterial dissection or perforation due to IAT, embolism in other vascular territories, allergic contrast medium reaction, pneumonia, cardiac ischemia and venous thromboembolism.
8 4. Version June 06, 2017 MR CLEAN R study protocol. BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION. Patients participating in the registry will undergo a second CT scan after 2 days, if clinically indicated. All patients will have an interview at three months. Patients undergoing endovascular treatment may need sedation or anesthesia and intubation during the procedure. Finally, endovascular treatment is associated with increased risk of intra-cerebral hemorrhage. The decision for endovascular treatment in a patient will be made by the treating physician on the basis of a professional estimate of the risk and benefits involved.
9 DISCUSSION. MR CLEAN-R is a post-trial registry of the MR CLEAN trial. Enrollment has been started after the last inclusion in the MR CLEAN trial (March 17 2014) and will continue after the start of the MR CLEAN II trials in the (COllaboration for New TReatments of Acute STroke (CONTRAST) consortium. Key words: alteplase, endovascular treatment , endovascular thrombectomy, acute ischemic stroke, post- trial cohort registry . 5. Version June 06, 2017 MR CLEAN R study protocol. 1. INTRODUCTION AND RATIONALE. GENERAL INTRODUC TION.)
10 1, 2. In Western Europe and the US, the annual incidence of ischemic stroke is 1-2 per 1000. Half of all patients with stroke die or remain severely disabled. Stroke is one of the major causes of death and the first cause of dependency in the western world. treatment with intravenous (IV) alteplase, aiming at early reperfusion has been proven effective for these patients, when they are treated within hours, and 3-5. when there are no contra-indications. The absolute reduction in the chance of poor outcome in patients 6.