SOLITAIRE™ with the Intention for Thrombectomy (SWIFT) Trial: Design of a Randomized, Controlled, Multicenter Study Comparing the SOLITAIRE™ Flow Restoration Device and the MERCI Retriever in Acute Ischaemic Stroke
- 6 November 2012
- journal article
- research article
- Published by SAGE Publications in International Journal of Stroke
- Vol. 9 (5), 658-668
- https://doi.org/10.1111/j.1747-4949.2012.00856.x
Abstract
Self-expanding stent retrievers are a promising new device class designed for rapid flow restoration in acute cerebral ischaemia. The SOLITAIRE™ Flow Restoration device (SOLITAIRE) has shown high rates of recanalization in preclinical models and in uncontrolled clinical series. (1) To demonstrate non-inferiority of SOLITAIRE compared with a legally marketed device, the MERCI Retrieval System®; (2) To demonstrate safety, feasibility, and efficacy of SOLITAIRE in subjects requiring mechanical thrombectomy diagnosed with acute ischaemic stroke. Multicenter, randomized, prospective, controlled trial with blinded primary end-point ascertainment. Key entry criteria include: age 22–85; National Institute of Health Stroke Scale (NIHSS) ≥8 and <30; clinical and imaging findings consistent with acute ischaemic stroke; patient ineligible or failed intravenous tissue plasminogen activator; accessible occlusion in M1 or M2 middle cerebral artery, internal carotid artery, basilar artery, or vertebral artery; and patient able to be treated within 8 h of onset. Sites first participate in a roll-in phase, treating two patients with the SOLITAIRE device, before proceeding to the randomized phase. In patients unresponsive to the initially assigned therapy, after the angiographic component of the primary end-point is ascertained (reperfusion with the initial assigned device), rescue therapy with other reperfusion techniques is permitted. The primary efficacy end-point is successful recanalization with the assigned study device (no use of rescue therapy) and with no symptomatic intracranial haemorrhage. Successful recanalization is defined as achieving Thrombolysis In Myocardial Ischemia 2 or 3 flow in all treatable vessels. The primary safety end-point is the incidence of device-related and procedure-related serious adverse events. A major secondary efficacy end-point is time to achieve initial recanalization. Additional secondary endpoints include clinical outcomes at 90 days and radiologic haemorrhagic transformation.Keywords
This publication has 18 references indexed in Scilit:
- Rescue, Combined, and Stand-Alone Thrombectomy in the Management of Large Vessel Occlusion Stroke Using the Solitaire Device: A Prospective 50-Patient Single-Center StudyStroke, 2011
- Mechanical Thrombectomy with a Self-Expanding Retrievable Intracranial Stent (Solitaire AB): Experience in 26 Patients with Acute Cerebral Artery Occlusion: Fig 1.American Journal of Neuroradiology, 2011
- Heart Disease and Stroke Statistics—2011 UpdateCirculation, 2011
- Mechanical thrombectomy in severe acute stroke: preliminary results of the Solitaire stent: Table 1Journal of Neurology, Neurosurgery & Psychiatry, 2011
- Mechanical Thrombectomy With the Solitaire AB Device in Large Artery Occlusions of the Anterior CirculationStroke, 2010
- Solitaire Flow-Restoration Device for Treatment of Acute Ischemic Stroke: Safety and Recanalization Efficacy Study in a Swine Vessel Occlusion ModelAmerican Journal of Neuroradiology, 2010
- The Penumbra Pivotal Stroke TrialStroke, 2009
- Guidelines for the Early Management of Adults With Ischemic StrokeStroke, 2007
- Safety and Efficacy of Mechanical Embolectomy in Acute Ischemic StrokeStroke, 2005
- Thrombolytic Therapy of Acute Basilar Artery OcclusionStroke, 1996