DEXTERITY-AFP (CIP0217 v.1.6)
Research type
Research Study
Full title
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation after Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
IRAS ID
301126
Contact name
Kirk Seward
Contact email
Sponsor organisation
Mercator MedSystems, Inc.
Eudract number
2021-002798-24
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 up to 14 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 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.
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0763
Date of REC Opinion
5 Jan 2022
REC opinion
Further Information Favourable Opinion