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NCT01716117 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
A NA study of Brain Aneurysm, sponsored by Stryker Neurovascular.
- Completed
- Registry status
- NA
- Development phase
- 213
- Enrollment target
- 20
- Study locations
NCT01716117 is a NA study of Brain Aneurysm that has completed, run by Stryker Neurovascular. The registered enrollment target is 213 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT01716117, a NA study of Brain Aneurysm, has completed, sponsored by Stryker Neurovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 213 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into or around the brain. The information collected from this study will be used to evaluate how well patients do when treated with the Surpass System both immediately after treatment of an aneurysm and over a long period of time (5 years).
Conditions Studied
Interventions
- DEVICE Surpass Flow Diverter
Study Locations (20)
Florida
- University of Florida - Gainesville
- Lyerly Neurosurgery/Baptist Health System - Jacksonville
- Mayo Clinic - Florida - Jacksonville
- Baptist Hospital of Miami - Miami
- Tampa General Hospital - Tampa
California
- University of California - Irvine
- Santa Barbara Cottage Hospital - Santa Barbara
New York
- University at Buffalo - Buffalo
- Columbia University - New York
Tennessee
- Fort Sanders Medical Center - Knoxville
- Vanderbilt University Medical Center - Nashville
Illinois
- Rush University Medical Center - Chicago
Kansas
- The University of Kansas Medical Center - Kansas City
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- University of Massachusetts Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2012-10-25 |
| Est. Completion | 2022-07-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01716117
The ClinicalTrials.gov registry entry for NCT01716117 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 213 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stryker Neurovascular, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Brain Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which Surpass Flow Diverter is the first listed.
NCT01716117 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, California, New York.
Frequently Asked Questions
What is clinical trial NCT01716117 about?
NCT01716117 is a clinical study titled "Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms". This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain....
What is the current status of trial NCT01716117?
This trial is currently completed. It is a NA study. The enrollment target is 213 participants. The study started on 2012-10-25. Estimated completion is 2022-07-07.
What conditions does trial NCT01716117 study?
This clinical trial studies the following conditions: Brain Aneurysm.
What interventions are being tested in trial NCT01716117?
The interventions under investigation include: Surpass Flow Diverter (DEVICE).
Who is sponsoring clinical trial NCT01716117?
This trial is sponsored by Stryker Neurovascular, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01716117 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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