News and upcoming events
200th MR CLEAN NO IV patient included
The Isala Hospital in Zwolle included the 200th patient in the MR CLEAN NO IV. We would like to thank all centers for their inclusions and efforts!
ESOC 2019: NO IV Investigator’s meeting
During this year’s ESOC in Milan, we hosted a meeting for all participating investigators to provide an update and discuss the progress of the trial. We are very pleased with the progress thus far and would like to thank all investigators for their time and effort. Below, you will find a brief summary and a selection of photos. We hope to see everyone at ESOC 2020 in Vienna!
- Current number of inclusions: 194
- Speed of inclusion: 20-25/month
- Actively including centers: 14
- 1st interim analysis: June 6th
- Parallel trials: DIRECT-MT (China), SWIFT DIRECT (Switzerland/Europe, Canada),DIRECT SAFE (Australia), SKIP (Japan). Agreements for individual patient data pooling to enable dequate investigation of subgroups have been made with the DIRECT-MT trial, and are being discussed with the other trials. We hope to enable a joint analysis and close collaboration.
- Deferred consent: shortens time to treatment, although may contribute to randomization of patients that are actually ineligible.
- Randomization errors: so far, 6 patients were randomized though they turned out to be ineligible for endovascular thrombectomy (EVT). These patients are included in the intention-to-treat analysis, so their consent and follow-up imaging is required. They will be excluded from the per-protocol analysis. Several tips were exchanged to diminish the chance of ‘ineligible’ randomization –for example, calling the neuro-interventionalist in advance to assess CTA imaging of a possible EVT candidate, to quickly determine EVT eligibility.
- Treatment times: door to needle times increased slightly in centers (ca. 5 minutes) due to CTA assessment for EVT eligibility before administering intravenous thrombolysis (IVT). Compared to international benchmarks, median door to needle times in the NO IV trial are still low.Median door to groin times are below the desired maximum of 60 minutes. There is some variation between centers and patients.
- Choice of device: the current protocol states that the first-line treatment modality during EVT must be a stent-retriever. However, an increasing number of trials suggesting non-inferiority of aspiration as first line of defense is published (ASTER, COMPASS, ASTER-2 presented at this year’s ESOC). The steering committee will discuss the possibility to leave the device choice to the treating interventionalist.
- DSA: important secondary and safety outcomes of the NO IV trial can only be assessed on DSA. These outcomes include pre-interventional recanalization, successful reperfusion by EVT, and embolization in new territory during EVT. DSA images should contain:
- pre-EVT series with AP and lateral directions, complete up to the venous phase, and
- post-EVT series with AP and lateral directions, complete up to the venous phase.
- Follow-up imaging: also necessary to determine secondary (recanalization rate, final infarct volume), and safety outcomes (infarct in new territory). Complete follow-up imaging consists of 24-48-hour MRI (FLAIR, DWI, T2*, 3D TOF) or 24+/-12 hour NCCT and CTA plus 5-7 days/discharge NCCT. Automatic assessment tools such as final infarct volume measurement are being developed now, and will be used in the assessments of the trial images.
- Imaging SOPs can be found on: https://www.contrast-consortium.nl/work-packagesinfo-2/wp7-imaging-data-management/
For the full presentation slides, click here.
Finally and most importantly, we would once again like to emphasize our appreciation for and recognition of everyone’s great efforts for the data collection, discussions and communication about complex cases, thinking about solutions, and suggestions on how to move forward. All trial nurses, PI’s, PhD students, research assistants, residents, doctors, technicians – thank you, we hope to continue the promising progress made so far!
ESOC 2019: MR CLEAN NO IV poster presentation
The progress of the MR CLEAN NO IV trial was presented as a poster during this year’s ESOC in Milan, by trial PhDs Natalie LeCouffe, Kilian Treurniet, and Manon Kappelhof. We were pleased to discuss the challenges and achievements of the trial so far, and are looking forward to our next poster presentation at the CONTRAST consortium meeting in Groningen, June 12th.