AWARD Study
Research type
Research Study
Full title
Adjunctive Wide-neck Aneurysm Reconstruction Device
IRAS ID
180716
Contact name
Hans-Christean Nahser
Contact email
Sponsor organisation
Pulsar Vascular, Inc.
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
The proposed research is a prospective, multi-center, single arm study with no randomization. The research is designed to evaluate the safety of the medical device in patients undergoing treatment for specific aneurysms (a localized, blood-filled balloon-like bulge in the wall of a blood vessel). The objective is to enroll up to 30 patients up to 10 sites worldwide. Patients will undergo follow-up assessments immediately after the procedure, prior to discharge and at 30 days, 180-days and 365 days after the procedure. Patient enrollment is anticipated for the 1st half of 2015, completion of patient enrollment in the 2nd half of 2015. Completion of patient follow-up is anticipated in the 2nd half of 2016.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0616
Date of REC Opinion
7 Sep 2015
REC opinion
Further Information Favourable Opinion