SEALANT
Research type
Research Study
Full title
SEALANT: Safety and Effectiveness Analysis of stent assisted coiling with LVIS® Evo™ and HydroCoil® Embolic System in ANeurysm Treatment
IRAS ID
303268
Contact name
Jonathan Downer
Contact email
Sponsor organisation
MicroVention Europe
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 5 months, 1 days
Research summary
This is an observational study. Treatments and follow-up visits will be done as per standard of care. There are no additional procedures or tests.
The objective of this study is to demonstrate that use of stent-assisted coiling using LVIS® Evo™ and HydroCoil® Embolic System (HES) in intracranial aneurysm treatment is effective and safe when assessed at 1 year after the procedure.
Both devices are CE-marked and will be used in their approved indication.
It is planned to includ approximately 200 patients in up to 20 sites in the UK and EU countries. Patients presenting with an unruptured or ruptured (> 30 days since occurrence) intracranial aneurysm eligible for endovascular treatment using LVIS® Evo™ and HydroCoil® Embolic System (HES) are eligible for this study.
The expected approximate study duration is 54 months, wtih an 18 months enrollment period and up to 36 months of follow-up period.
As this is an observational study with no additional procedures to standard of care, only patients medical data will be collected.REC name
West of Scotland REC 5
REC reference
21/WS/0127
Date of REC Opinion
19 Nov 2021
REC opinion
Further Information Favourable Opinion