NCT03994822

pRESET for Occlusive Stroke Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: phenox Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion

Detailed description

To determine the safety and effectiveness of pRESET for the treatment of acute ischemic stroke within 8 hours of symptom onset (defined as time patient was last seen well) due to large vessel occlusion and to compare safety and effectiveness to the predicate device, Solitaire™ Platinum revascularization device

Conditions

• Brain Diseases
• Cardiovascular Diseases
• Central Nervous System Diseases
• Cerebrovascular Disorders
• Ischemia
• Nervous System Diseases
• Pathologic Processes
• Stroke, Ischemic
• Stroke, Acute
• Vascular Diseases

Interventions

Type	Name	Description
DEVICE	Mechanical Thrombectomy using the pRESET Thrombectomy device	Clot removal using the pRESET Thrombectomy device
DEVICE	Mechanical Thrombectomy using the Solitaire Revascularization Device	Clot removal using the Solitaire Revascularization Device

Timeline

• Start date: 2019-10-04
• Primary completion: 2022-05-12
• Completion: 2022-05-12
• First posted: 2019-06-21
• Last updated: 2023-04-21

Locations

24 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study