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Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
NCT01716117 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01716117 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01716117?
The interventions under investigation include: Surpass Flow Diverter (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01716117?
This trial is sponsored by Stryker Neurovascular, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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