Table 8

Center requirements to participate in the main thrombectomy trials showing a benefit of MT plus BMM versus BMM alone

TrialCriteria
MR CLEAN1
  • The intervention team should have ample experience with endovascular interventions for cerebrovascular disease, peripheral artery disease, or coronary artery disease. At least one member of the intervention team should have sufficient experience with intra‐arterial thrombolysis (IAT).

  • … At least one member of the intervention team should have sufficient experience with the particular device (defined as completion of at least five full procedures with the particular device). Procedures that have been carried out by two team members (for example, in a training setting) count. Procedures do not need to be successful, or uncomplicated. Procedures consisting of mechanical thrombectomy combined with IAT count for both.

  • … The possibility of treatment by an interventionalist with sufficient experience is listed as an inclusion criterion.’

EXTEND IA2 Sites were required to have an established intravenous rtPA program with multimodal CT or MRI as standard procedure.
ESCAPE3 Sites were required to employ CTA as standard of care for patients with acute stroke and have effective systems for identification of patients.
In addition, the protocol stated that ’the quality of intervention will be ensured by hand-selection of sites and only be approved by the executive committee after a site visit. All sites must submit evidence within the 2 years prior to commencement of the trial that they can meet the 90 min target of CTA‐to‐recanalization time. A key and critical component of the trial will be an ongoing quality assurance programme to ensure that sites can meet these targets for endovascular intervention. Training will be undertaken at the sites and continued on a quarterly basis. Monitoring of interval times will be collated and provided to sites on a quarterly basis so that regular feedback might induce appropriately fast treatment processes. Sites that fail to meet these objectives in the trial will be dropped from the trial.’
REVASCAT5 Conducted in the setting of a regional network of acute stroke care, covering a population of 7.5 million in a compact geographical region of Catalonia. No trial specified the characteristics of a network, only of individual participating centres.
SWIFT-PRIME4 In addition to general criteria related to GCP, other criteria were:
  • Previous experience with clinical research and mechanical thrombectomy procedures

  • Experience in conducting randomized, controlled, clinical studies

  • Currently treating subjects who meet the inclusion/exclusion criteria

  • Ability to enrol an adequate number of subjects

  • Ability and willingness to randomize study subjects

  • Ability to perform required clinical testing, including angiography, CT, and MRI

  • Adequate staffing to conduct the study.

THRACE15 No mention of specific centre requirements.
DAWN9 No mention of specific centre requirements.
DEFUSE-310
  • No mention of specific centre requirements

  • Interventionalists had to meet to following requirements:

    • Training: satisfactory completion of a 7-year ACGME approved neurosurgical residency OR Board certification (ABMS) Board in Neurology with subspecialty certification from an ACGME-accredited Vascular/Stroke Neurology Fellowship OR Board certification (ABMS) Board (Radiology) with subspecialty certification in neuroradiology AND interventionalist has completed a minimum of 12 months of continuous training as a fellow in a dedicated neuroendovascular fellowship

    • Experience: interventionalist has performed a minimum of 200 cerebral angiograms AND has performed at least 20 stroke thrombectomy cases with stent retrievers and/or suction thrombectomy devices as a primary operator. (When a prospective interventionalist had extensive experience performing endovascular thrombectomies, but did not fully meet the training requirements, they could be approved by unanimous vote of the four-member DEFUSE-3 endovascular committee.)