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NCT04195568 · ClinicalTrials.gov registry record · NA
Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System
A NA study of Aneurysm, Intracranial, sponsored by Stryker Neurovascular.
- Active
- Registry status
- NA
- Development phase
- 248
- Enrollment target
- 20
- Study locations
NCT04195568: Active NA study of Aneurysm, Intracranial, sponsored by Stryker Neurovascular.
NCT04195568 is a NA study of Aneurysm, Intracranial that is active but no longer recruiting, run by Stryker Neurovascular. The registered enrollment target is 248 participants, above the 216-participant average among 3 other Aneurysm, Intracranial trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04195568, a NA study of Aneurysm, Intracranial, is active but no longer recruiting, sponsored by Stryker Neurovascular.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 248 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches
Primary Outcome
The primary effectiveness endpoint of this study is a composite of 100% occlusion (Raymond 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (\>50% stenosis), per independent core lab assessment of digital subtraction angiography (DSA) images acquired at 12 months (± 3 months) post-procedure, and with no target aneurysm retreatment.
Conditions Studied
Interventions
- DEVICE Surpass Evolve Flow Diverter System
Study Locations (20)
Florida
- Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery - Jacksonville
- Mayo Clinic Florida - Jacksonville
- Baptist Hospital of Miami - Miami
- Tallahassee Neurological Clinic - Tallahassee
Massachusetts
- Tufts Medical Center - Boston
- Beth Israel Deaconess Medical Center - Boston
- Lahey Clinic - Burlington
- University of Massachusetts - North Worcester
Arizona
- DIGNITY HEALTH/ Barrow Neurological Institute - Phoenix
- St. Joseph's Hospital - Tucson
California
- University of California, Los Angeles - Los Angeles
Illinois
- Advocate Lutheran General Hospital - Park Ridge
Indiana
- Indiana University - Indianapolis
Iowa
- University of Iowa - Iowa City
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2020-07-07 |
| Est. Completion | 2028-09-13 |
| Phase | NA |
What the registry record for NCT04195568 still lists
NCT04195568 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, above the 216-participant average among 3 other Aneurysm, Intracranial trials with a reported enrollment target (15% higher).
The record links to 1 condition, with Aneurysm, Intracranial appearing as the primary indexed condition, and to 1 intervention - of which Surpass Evolve Flow Diverter System is the first listed.
NCT04195568 names 20 study sites across 13 states, led by Florida, Massachusetts, Arizona.
Frequently Asked Questions
What is clinical trial NCT04195568 about?
NCT04195568 is a clinical study titled "Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System". The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches
What is the current status of trial NCT04195568?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 248 participants. The study started on 2020-07-07. Estimated completion is 2028-09-13.
What conditions does trial NCT04195568 study?
This clinical trial studies the following conditions: Aneurysm, Intracranial.
What interventions are being tested in trial NCT04195568?
The interventions under investigation include: Surpass Evolve Flow Diverter System (DEVICE).
Who is sponsoring clinical trial NCT04195568?
This trial is sponsored by Stryker Neurovascular, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04195568 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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