NCT01716117

Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms

The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Stryker Neurovascular · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The objective of this study is to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus. The Surpass Flow Diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm. Use of the Surpass System may be associated with a decrease in neurological death or ipsilateral stroke in patients with large or giant wide-neck aneurysms. In a given patient, the Surpass System will be deemed effective if treatment results in complete occlusion of their aneurysm without clinically significant stenosis of the parent artery, or requires retreatment of the aneurysm through 12 months.

Conditions

• Brain Aneurysm

Interventions

Type	Name	Description
DEVICE	Surpass Flow Diverter	Treatment of an intracranial aneurysm involves the placement of a specially designed metallic mesh tube in a vessel in the brain where an aneurysm is located. The device looks like a fishnet sock with both ends open. Each device is delivered through a small catheter (a long, flexible tube). The catheter containing the device is inserted and advanced into a vessel in the brain. The device is then placed in the brain vessel by releasing it from the catheter. Once the device is placed inside the brain vessel, it is intended to reinforce the area of the vessel that is weakened and bulging (the aneurysm), and to cause blood to flow down the vessel and away from the aneurysm while allowing blood in the aneurysm to clot. This procedure is called an endovascular aneurysm treatment because the device is delivered through the blood vessels.

Timeline

• Start date: 2012-10-25
• Primary completion: 2016-12-11
• Completion: 2022-07-07
• First posted: 2012-10-29
• Last updated: 2022-12-19
• Results posted: 2019-07-23

Locations

26 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated device study