Robust Data for Safety and Efficacy

SWIFT PRIME

The SWIFT PRIME¹ study was a global, multicenter, two-arm, prospective, randomized, open, blinded-endpoint (PROBE) trial to compare the functional outcomes in acute ischemic stroke (AIS) subjects treated with either IV t-PA alone or IV t-PA in combination with the Solitaire™ revascularization device.

STUDY CONCLUSION

In patients receiving intravenous t-PA for acute ischemic stroke with confirmed large-vessel occlusions of the anterior circulation, treatment with the Solitaire™ stent thrombectomy device within 6 hours after symptom onset improved functional outcomes at 90 days.

ESCAPE

The ESCAPE³ trial was an investigator-initiated, multi-center, prospective, randomized, open, blinded-endpoint (PROBE) trial designed to test whether patients with acute ischemic stroke, who were selected on the basis of results of CT and CTA, would benefit from rapid endovascular treatment involving contemporary endovascular techniques.  

Patients were allocated 1:1 to endovascular treatment plus guideline-based care (intervention) vs. guideline-based care alone (control).

STUDY CONCLUSION

Among acute ischemic stroke patients with proximal vessel occlusion, small infarct core, and moderate-to-good collaterals, rapid endovascular treatment improved functional outcomes and reduced mortality.

REVASCAT

REVASCAT⁴ was an investigator-initiated, multicenter, prospective, randomized, sequential, open, blinded-endpoint (PROBE) study in acute ischemic stroke patients who had contraindications to IV t-PA or had received IV t-PA therapy within 4.5 hours without revascularization after 30 minutes of IV t-PA.

It was conducted to determine the efficacy and safety of neurovascular thrombectomy with the Solitaire™ FR device in conjunction with medical therapy versus medical therapy alone, among eligible acute ischemic stroke patients treatable within 8 hours of symptom onset.

STUDY CONCLUSION

In patients with anterior circulation stroke treatable within 8 hours of symptom onset, stent retriever thrombectomy reduces post-stroke disability and increases the rate of functional independence.

MR CLEAN

MR CLEAN⁵ was a randomized trial of intra-arterial treatment (IAT) for acute stroke. In patients with acute ischemic stroke caused by proximal intracranial arterial occlusion, IAT is highly effective for emergent revascularization. Five hundred patients with a proximal arterial occlusion in the anterior cerebral circulation demonstrated on vessel imaging, treated with IAT within 6 hours were randomized to IAT plus usual care (IV t-PA or medical management) or usual care alone.

STUDY CONCLUSION

The MR CLEAN study observed that the addition of stent thrombectomy for acute ischemic stroke care is safe and effective when administered within 6 hours of symptom onset.

STRATIS

The STRATIS Registry⁶ was a prospective, multi-center, observational, single-arm study that was designed to investigate the ‘real-world’ stroke care questions and build a comprehensive representation of the patient population being treated with Medtronic stent retrievers.

The STRATIS Registry tracked the system of care data including transfer distances, referral patterns, times and location of stroke onset to ultimate interventional treatment. Patient images as well as techniques were independently core lab adjudicated. STRATIS is the first registry to enroll 984 patients within 8 hours from stroke onset with a focus on systems of care on clinical outcomes.

• Read key findings – Systems of Care
• Read key findings – Procedural Techniques
• Read original article

STUDY CONCLUSION

Solitaire™ thrombectomy for large vessel ischemic stroke was safe and highly effective with substantially reduced disability. Benefits were consistent in all prespecified subgroups.