Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Brain Aneurysm, sponsored by Stryker Neurovascular.
NCT01716117 is a NA study of Brain Aneurysm that has completed, run by Stryker Neurovascular. The registered enrollment target is 213 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit.
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 |
What the finished NCT01716117 record still lists
NCT01716117 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Brain Aneurysm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01716117's enrollment target sits among peer trials
213 488th of 2000 higher than 1,512 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06476886 · 213 participants · NA
Intensive Crisis Intervention
- NCT06544655 · 213 participants · Phase 1
A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
- NCT07186816 · 213 participants · NA
SUpport From PEeRs to Expand Access Study - Community
- NCT04030507 · 214 participants · NA
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI