NCT02347358

Mechanical Opening Device Implantation Following Intravenous r-tPA for Recanalization in Acute Ischemic Stroke

Mechanical Opening Device Implantation Following Intravenous r-tPA and Recanalization Outcome Evaluation in Stroke Disease (MODIFIED) Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The Second Artillery General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to test a hypothesis that temporary implantation of JRecanTM blood flow recanalisation device within 6.5 hours of symptom onset of acute ischemic stroke due to a major intracranial artery occlusion following IV r-tPA can provide a greater rate of early successful recanalisation than treatment of IV r-tPA alone.

Conditions

• Ischemic Cerebrovascular Accident

Interventions

Type	Name	Description
DEVICE	JRecanTM blood FR device	JRecanTM blood flow recanalisation device
DRUG	IV r-tPA	intravenous recombinant human tissue plasminogen activator

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-01-01
• Completion: 2017-04-01
• First posted: 2015-01-27
• Last updated: 2015-01-27