NCT01492725

Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial

A Randomized Controlled Trial of Intra-arterial Reperfusion Therapy After Standard Dose Intravenous t-PA Within 4.5 Hours of Stroke Onset Utilizing Dual Target Imaging Selection.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Neuroscience Trials Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients presenting to the emergency department with acute ischaemic stroke, who are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for "dual target" major vessel occlusion and mismatch to determine their eligibility for randomisation into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to intra-arterial clot retrieval after IV tPA or IV tPA alone. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Intra-arterial Clot Retrieval with Solitaire device	Intra-arterial mechanical clot retrieval with the Solitaire device after patients have received standard therapy with intravenous tissue plasminogen activator (tPA). Clot retrieval involves cerebral angiography and takes approximately 2 hours.
GENETIC	intravenous tissue plasminogen activator (tPA)	Standard care IV tPA therapy administered as per registered product information

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-12-15
• Last updated: 2015-04-21

Locations

9 sites across 2 countries: Australia, New Zealand