Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands.

Endovascular treatment increases the likelihood of recanalization in patients
with acute ischemic stroke caused by proximal intracranial arterial occlusion.
The purpose of the Multicenter Randomized Clinical trial of Endovascular
treatment for Acute ischemic stroke in the Netherlands (MR CLEAN) is to assess
the safety and effect on functional outcome of endovascular treatment in these
patients.

The primary objective of this study is to estimate the effect of endovascular
treatment on overall functional outcome after acute ischemic stroke of less
than six hour duration, in patients with a symptomatic anterior circulation
IAO. The secondary objectives are to assess the overall safety of endovascular
treatment with regard to the occurrence of hemorrhagic and ischemic
complications, the efficacy with regard to obtaining recanalization, and to
evaluate predictors of recanalization, including imaging aspects and hemostatic
parameters. Moreover, we want to assess the safety and efficacy of different
types of endovascular treatment (i.e. mechanical treatment, intra-arterial
thrombolysis) different combinations of treatment (i.e. with intravenous rtPA)
and different timings of treatment. Tertiary objectives are to carry out case
studies of implementation strategies and loco-regional solutions for barriers
to the delivery of endovascular treatment for acute ischemic stroke and to
collect data for cost-effectiveness analysis of endovascular treatment compared
with standard treatment.

MR CLEAN is a pragmatic phase III multicenter randomized clinical trial with
blinded outcome assessment. We compare endovascular treatment (intra-arterial
thrombolysis, mechanical treatment or both) with no treatment, against a
background of optimal medical management, which may include intravenous
alteplase.
The exact choice of endovascular treatment modality for each patient is left to
the discretion of the local investigator and treating physicians. The steering
committee will provide recommendations and guidelines for treatment and
selection of patients in the study.

The intervention contrast is endovascular treatment versus no endovascular
treatment. The treatment is provided in addition to best medical management
(aspirin, stroke unit treatment and intravenous thrombolysis if indicated).

Intra-arterial treatmetn consists of intra-arterial thrombolysis with alteplase
or urokinase, and/or mechanical treatment (stenting, aspiration or retraction
of the thrombus). Specific recommendations with regards to procedures and
devices will be issued by the trial steering committee and are listed in
appendix 3.

All patients that participate in the trial will undergo a second CTA within 24
hours after admission and an CT scan at day 5-7. All patients will have a
telephone interview at three months. Future patients will be included in the
economic evaluation of the MR CLEAN. In addition to an economic questionnaire
they will undergo a telephonic interview with an interval of 6 months.

In case patients are randomized for intra-arterial treatment they sometimes
need sedation or anesthesia and intubation during the procedure. Endovascular
treatment is associated with increased risk of intra-cerebral hemorrhage.

Adverse events are listed in paragraph 7.1 (page 18) of the protocol.