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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

Authors


  • Conflict of interest: The University of California, Regents receive funding for Dr. Saver's services as a scientific consultant regarding trial design and conduct to Covidien/ev3, BrainsGate, CoAxia, Grifols/Talecris, Ferrer, Mitsubishi, Genervon, Benechill, Asubio, and Sygnis. Dr. Saver is an investigator in the NIH FAST-MAG, MR RESCUE, ICES, CUFFS, CLEAR-ER and IMS 3 multicenter clinical trials for which the UC Regents receive payments based clinical trial performance; has served as an unpaid site investigator in a multicenter trials run by Covidien/ev3, Genervon, Lundbeck, and Mitsubishi for which the UC Regents received payments based on the clinical trial contracts for the number of subjects enrolled; and is an employee of the University of California, which holds a patent on retriever devices for stroke. The University of California, Regents receive funding for Dr. Jahan's services as a scientific consultant regarding trial design and conduct to Covidien/ev3 and Chestnut Medical, and is an employee of the University of California, which holds a patent on retriever devices for stroke. Dr. Levy serves as a scientific consultant for Covidien/ev3, Codman & Shurtleff, Inc, and TheraSyn Sensors, Inc; and receives fees for carotid stent training from Covidien/ev3 and Abbott Vascular. and ev3/Covidien Vascular Therapies. Dr. Jovin has served as a scientific consultant to Covidien/ev3, CoAxia, Concentric Medical, and Micrus. Dr. Nogueira has served as a scientific consultant to Covidien/ev3, CoAxia, and Concentric Medical. Dr. Clark and Dr. Budzik have served as scientific consultants to Covidien/ev3. Dr. Zaidat serves as a scientific consultant to Talecris Biotherapeutics, Stryker, Codman, and MicroVention.

Abstract

Rationale 

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.

Aims 

(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.

Design 

Multicenter, randomized, prospective, controlled trial with blinded primary end-point ascertainment.

Study Procedures 

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.

Outcomes 

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 end-points include clinical outcomes at 90 days and radiologic haemorrhagic transformation.

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