FRED/FRED Jr Intracranial Aneurysm Treatment Study (FRITS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03920358|
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment|
|Intracranial Aneurysm||Device: FRED and FRED Jr|
This is a multi-center observational study. Treatment and follow-up visits will be performed as per standard of care. The purpose of this study is to demonstrate that use of the FREDTM/FREDTM Jr Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 6, 12 months and yearly up to 5 years post procedure.
150 patients will be enrolled over an 15-month recruitment period. All patients will be followed for 5 years.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||FRED/FRED Jr Intracranial Aneurysm Treatment Study|
|Actual Study Start Date :||April 10, 2019|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||September 30, 2024|
- Device: FRED and FRED Jr
Subjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysmOther Name: Flow Re-Direction Endoluminal Device
- Rate of complete aneurysm occlusion without associated stenosis of the parent artery (> 50%) [ Time Frame: 12 months ]
Complete occlusion (Raymond Scale grade I) without stenosis of the parent artery.
Raymond scale definition: Grade I= complete occlusion of aneurysm, Grade II= Residual neck, Grade III= Residual aneurysm
- Morbidity Rate [ Time Frame: 6 months ]Patients with mRS>2
- Mortality Rate [ Time Frame: 6 months ]Deaths within 6 months after treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920358
|Contact: Laurence Bousquet, PhDemail@example.com|
|Contact: Patricia Boyerfirstname.lastname@example.org|
|Erlangen, Germany, D-91054|
|Contact: Arnd Dörfler, Prof. Dr. med.|
|Principal Investigator:||Arnd Dörfler, Prof. Dr. med.||Universitätsklinikum Erlangen|