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The field of neurointerventional surgery (NIS) has undergone a truly remarkable maturation over the past decade. This maturation is largely based upon two fundamental, but sometimes seemingly diametrically opposed, factors. First, industry-driven research and development provides us with new devices at an accelerating pace. Some are truly novel (eg, flow diverters) and allow the treatment of cerebrovascular diseases which were previously untreatable or poorly managed. Others represent iterative improvements of existing techniques and technologies, which make our procedures safer, faster, easier, and ultimately, more effective (eg, stent-retrievers and aspiration catheters). Second, a dramatic transition has occurred from a practice based almost entirely on personal case experience and single-center, retrospective series, to an evidence-based practice, supported by data derived from one or more randomized controlled trials (RCTs).
In diseases where no endovascular device or technique has been shown to be effective, RCTs are required, when feasible, to establish efficacy over standard management—typically either medical management or conventional open surgical treatment. These RCTs, from the International Subarachnoid Aneurysm Trial (ISAT) and Barrow Ruptured Aneurysm Trial (BRAT) for ruptured aneurysms to the recent series of thrombectomy trials for emergent large vessel occlusion (ELVO), have fundamentally advanced medicine and established endovascular therapies as the new standards of care for certain cerebrovascular diseases.1–7 Similarly, trials such as Stenting And Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS), have led to the re-evaluation of endovascular treatment while advancing the status of aggressive medical management, again resulting in the development of a new standard of care.8
Despite the unambiguous merits of RCTs, there are many situations in NIS where they may not be feasible. These include:
1. At the introduction of a new device. In the field of NIS, regulatory clearance, whether it be by premarket approval (PMA) (eg, the Pipeline embolization …
Competing interests DF: consultant – Penumbra, Codman JnJ, Medtronic, Sequent, Vascular Simulations; research support – Sequent, Microvention, Siemens. JM: consultant – Lazarus Effect, Reverse, Pulsar, Edge Therapeutics, Medina; investor – Blockade Medical, Medina, Lazarus Effect. AA: research support – Sequent and Siemens; consultant – Microvention, Johnson and Johnson, Medtronic, Penumbra, Silk Road, Stryker, Sequent; stock – Lazarus Effect and Valor. AS: consultant – Codman & Shurtleff Inc, Covidien Vascular Therapies, GuidePoint Global Consulting, Penumbra, Stryker, Pulsar Vascular, Microvention, Lazarus Effect, Blockade Medical, Reverse Medical, WL Gore & Associates, Medina Medical, Cervetech Inc, Neuroavi, Perflow Medical, Silkroad Medical, TRES Medical, Syntervention; research grants – The National Institutes of Health; financial interests – Hotspur, Intratech Medical, StimSox, Valor Medical, Blockade Medical, Lazarus Effect, Pulsar Vascular, Medina Medical Inc; national steering committees – Penumbra, 3D Separator Trial, Covidien, SWIFT PRIME Trial, LARGE Trial, POSITIVE Trial, Codman, BRAVO Trial, Neuroavi, ARISE II Trial; advisory board – Codman & Shurtleff, Covidien Neurovascular, Inter–societal Accreditation Commission. DH: consultant – Stryker; investigator – Penumbra. AT: consultant, reserach gants – Penumbra, Stryker, Codman, Covidien, Microvention, Medina, Lazarus Effect, Pulsar Vascular, Siemens; stock – Medina, Lazarus Effect, Pulsar Vascular.
Provenance and peer review Commissioned; internally peer reviewed.