DEFIANCE version 2.0_NEW_Second Application
Research type
Research Study
Full title
DEFIANCE RCT of ClotTriever system vs. anticoagulation in deep vein thrombosis
IRAS ID
331452
Contact name
Taha Khan
Contact email
Sponsor organisation
Inari Medical Europe GmbH
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-23-01-042028, EUDAMED
Duration of Study in the UK
2 years, 7 months, 1 days
Research summary
The purpose of this clinical study is to compare 2 types of treatment for deep vein thrombosis (DVT). A DVT is a blood clot in a certain part of the leg which disturbs or even blocks the blood flow in the vessel and needs to be treated to avoid serious consequences. This study compares two methods for treating such DVTs. The treatment methods to be compared in this study are:
1. ClotTriever procedure plus anticoagulant (AC) medicine
2. Anticoagulant (AC) medicine alone
Patients are being asked to take part in this study because they are suffering from a DVT and that needs to be treated. If a patient decides to take part in this study, (s)he will receive treatment of the blot clot with either the ClotTriever procedure plus anticoagulant medicine or anticoagulant medicine alone.
The ClotTriever Thrombectomy System (referred to as “ClotTriever”) is a medical device designed to treat blood clots in the leg. The ClotTriever is a small device that can be introduced into a blood vessel to trap the clot and remove it from the vessel by pulling it out. Anticoagulants (AC) are a group of medicines that decrease the blood’s ability to clot. They do that by preventing new clots from forming. This medicine is often referred to as "blood thinners".REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0661
Date of REC Opinion
13 Oct 2023
REC opinion
Further Information Favourable Opinion