DEXTERITY-SCI (CIP0218 v1.6)
Research type
Research Study
Full title
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation after Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT
IRAS ID
299215
Contact name
Kirk Seward
Contact email
Sponsor organisation
Mercator MedSystems, Inc.
Eudract number
2021-002797-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This is a study of a medical procedure that utilizes an approved catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available and commonly used anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after removal of blood clots that have been symptomatic for at least 14 days and no more than 60 days. The goal of the study is to see if local anti-inflammation helps prevent re-clotting of the blood vessel and improvement in symptoms for several months after the initial procedure to remove the clot. The study will be performed at multiple sites (such as hospitals) and will have two phases. In the first phase, all participants will get local catheter-based delivery of dexamethasone sodium phosphate injection into the tissue around their vein after clot removal. In the second phase, half of participants will receive dexamethasone and the other half will receive a local placebo injection, in order to study what benefits may come from the study procedure. If additional procedures are needed within the first year after being enrolled in the study, the participant will receive the same investigational procedure as they received during the enrollment intervention.
REC name
London - London Bridge Research Ethics Committee
REC reference
21/LO/0764
Date of REC Opinion
10 Dec 2021
REC opinion
Further Information Favourable Opinion