TREAT (Rev AC)
Research type
Research Study
Full title
Trenza Embolization Device for Intrasaccular Aneurysm Treatment
IRAS ID
285688
Contact name
Jonathan Downer
Contact email
Sponsor organisation
Stryker Neurovascular (SNV)
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The purpose of the TREAT study is to assess the safety and performance of the Trenza device in the treatment of intracranial aneurysms. This device is being evaluated for use in the treatment of patients with an aneurysm in the brain. \nA brain (cerebral) aneurysm is a bulging, weak area in the wall of an artery that supplies blood to the brain. The study device received CE mark (European Conformity) for treatment of this type of aneurysm. \nThe Trenza device is used in a procedure called an endovascular aneurysm treatment because the device is delivered through the blood vessels. The device is a specially designed metallic coil implant that is delivered through a small catheter (a long, flexible tube) that is inserted into the brain from a starting point through a blood vessel in the leg (groin). One or more of the study device(s) is/are then placed in the brain aneurysm by moving it through the catheter to create a basket (frame). Once the device(s) is/are placed inside the brain aneurysm, additional coils will be implanted to fill in the aneurysm to create a tissue mass that fills the aneurysm and stops the flow of blood into the aneurysm. \nPatients with saccular intracranial aneurysms will be included in the study. A total of 106 patients will be enrolled in 15 European sites with expertise in the endovascular treatment of intracranial aneurysms. Patients will be followed up at 3 and 12 months as per hospital standard of care. \n
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0006
Date of REC Opinion
29 Jan 2021
REC opinion
Favourable Opinion