pRESET for Occlusive Stroke Treatment
NCT03994822 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340
Last updated 2023-04-21
Summary
Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion
Conditions
- Brain Diseases
- Cardiovascular Diseases
- Central Nervous System Diseases
- Cerebrovascular Disorders
- Ischemia
- Nervous System Diseases
- Pathologic Processes
- Stroke, Ischemic
- Stroke, Acute
- Vascular Diseases
Interventions
- 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
Sponsors & Collaborators
-
phenox Inc.
lead INDUSTRY
Principal Investigators
-
Raul G Nogueira, MD · University of Pittsburgh Medical Center, Pittsburgh
-
Richardo A Hanel, MD · Baptist Medical Center Jacksonville
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-04
- Primary Completion
- 2022-05-12
- Completion
- 2022-05-12
- FDA Device
- Yes
Countries
- United States
- Germany
Study Locations
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