Ongoing studies

DIVINE

The Dutch regIstry for endoVascular therapy IN ischaemic stroke with imaging Evaluation (DIVINE) is a longitudinal, observational registry that will prospectively enrol patients from comprehensive stroke centres in the Netherlands.
DIVINE is part of the ‘Collaboration for New TReatments of Acute Stroke 2.0’ (CONTRAST 2.0) consortium.

Kind regards,

On behalf of the DIVINE executive committee and the CONTRAST consortium,

Professor H. Bart van der Worp, MD PhD (neurologist, University Medical Center Utrecht, Principal Investigator)
Bart J. Emmer, MD PhD (interventional neuroradiologist, Amsterdam University Medical Centers, Principal Investigator)
Burak Konya, MD (PhD candidate, University Medical Center Utrecht, Coordinating Investigator)

Rationale and aim

Because of recent developments, findings in earlier observational studies like the MR CLEAN Registry may not be broadly applicable to current clinical practice anymore. Moreover, the MR CLEAN Registry and other registries lacked a level of detail to address clinically relevant questions, such as the outcomes of EVT in patients with a demarcated infarct or with specific thrombus or vessel characteristics on imaging, or with the use of newer devices. And notably, regulatory and re-imbursement bodies are increasingly seeking for real-world data on implementation and follow-up of new devices and techniques. The DIVINE registry will gather highly detailed data on EVT in patients with acute ischaemic stroke in current clinical practise in the Netherlands and use this data to answer key clinical questions.

Study design

Design

DIVINE is a longitudinal, observational registry that will prospectively enrol patients from comprehensive stroke centres in the Netherlands. The DIVINE registry is part of the ‘Collaboration for New TReatments of Acute Stroke 2.0’ (CONTRAST 2.0, see Appendix 1).

Population

All consecutive patients with acute ischaemic stroke who are treated with EVT in a participating comprehensive stroke centre. ‘Treatment with EVT’ is defined as arterial puncture with the aim of endovascular treatment. Patients who have been included in any concurrent RCT will also be registered but no separate analysis of their data will be performed before the public presentation of the main data of the relevant RCT.

In- and exclusioncriteria

To be eligible to participate in this registry, a subject must meet all the following criteria:

A clinical diagnosis of acute ischaemic stroke;
Extracranial carotid or intracranial arterial occlusion demonstrated with CTA, MRA, or DSA;
Initiation of EVT, defined as groin puncture;
Written informed consent in non-deceased patients.
A potential subject who meets the following criterium will be excluded from participation in this registry:
Patients under the age of 18 years.

Main study parameters

Score on the modified Rankin Scale (mRS) at 90 ± 14 days after stroke onset.

Secondary study parameters

Score on the National Institutes of Health Stroke Scale (NIHSS) at 24 to 48 hours after EVT;
Post-treatment score on the extended Thrombolysis In Cerebral Infarction scale (eTICI) assessed on DSA;
First-pass effect, i.e. whether excellent reperfusion (eTICI 2c-3) was achieved after the first attempt;
Total number of passes till end of procedure;
Groin-to-reperfusion time, i.e. the time from groin puncture till excellent reperfusion (eTICI 2c-3);
mRS at 365 ± 30 days after stroke onset;
Patient-reported outcomes up to 365 ± 30 days after stroke onset;
Costs up to 365 days after stroke onset.

Safety parameters

Death at 90 ± 14 days after stroke onset;
Neurological deterioration within 24 ± 6 hours of EVT. Neurological deterioration is defined as any decline in NIHSS of 4 points or more or 2 points or more in an NIHSS subcategory.25 This serious complication will be further classified as due to intracranial haemorrhage, ischaemia, or other (undetermined) cause;
Symptomatic intracranial haemorrhage within 24 hours of EVT according to the Heidelberg Bleeding Classification;26
Embolisation in a new territory during endovascular treatment;
Any other serious adverse event (SAE) during EVT or follow-up. Follow-up for SEAs is limited to the first seven days after stroke onset, or until hospital discharge, if earlier.

Informed consent

Written informed consent will be obtained from the patient or a representative by one of the investigators or a research nurse in one of the participating centres. We will strive to obtain consent as soon as possible. When the patient is not competent, the investigator will search for a legal representative available. If there is no legal representative available, obtaining consent will be postponed until a proxy is present. Subjects or their representatives will be provided with a patient information form (PIF) and a verbal explanation of the purpose of the study. They will be informed about the inclusion in the registry and data that will be collected. They will be asked for consent to be followed-up. Patients and their representatives will be provided as much time as necessary to decide whether they want to participate in the study. The patient or representative may, at any given time, withdraw informed consent. An explanation is not needed. A patient who has died before consent has been obtained will be included in the study. If a patient or representative decides to withdraw consent, already gathered data will be destroyed, with the exception of data that have already been used in a scientific manuscript.

Study protocol and documents

PIF

Organization

Principal Investigators

Professor H. Bart van der Worp, MD PhD (neurologist, University Medical Center Utrecht)
Bart J. Emmer, MD PhD (interventional neuroradiologist, Amsterdam University Medical Centers)

Coordinating investigator

Burak Konya, MD (PhD candidate, University Medical Center Utrecht)

Participating centers

Center	Location	Local investigator
AUMC	Amsterdam	B.J. Emmer
EMC	Rotterdam	B. Roozenbeek
HMC	Den Haag	I.R. van den Wijngaard
UMCU	Utrecht	H.B. van der Worp

Contact

Contact information DIVINE

Department of Neurology and Neurosurgery
University Medical Center Utrecht
3584 CX, Utrecht
Postbus 85500, 3508 GA, Utrecht
E-mail: divine@umcutrecht.nl
088-75 55 55 5

Coordinating investigator

Burak Konya, MD
Department of Neurology and Neurosurgery
University Medical Center Utrecht, Utrecht
Postbus 85500, 3508 GA, Utrecht

DIVINE Inclusieformulier

Gebruik dit form u lier om patiënten aan te melden voor de DIVINE follow-up. Dit formulier is niet bedoeld voor overleden deelnemers of deelnemers die primair voor een andere trial zijn geïncludeerd, zoals de CASES