NCT01657461

Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial

Solitaire™ FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary study objective is to determine if subjects experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS) than those subjects treated with IV t-PA alone

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)	Standard therapy with Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
DEVICE	Solitaire revascularization device	Clot retrieval with the Solitaire revascularization device after patients have received standard therapy with intravenous tissue plasminogen activator

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2012-08-06
• Last updated: 2017-05-18
• Results posted: 2017-05-18

Locations

1 site across 1 country: United States