RECANA-OUS-UK
Research type
Research Study
Full title
RECANA OUS: Recana Thrombectomy Catheter for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)
IRAS ID
354350
Contact name
Eric Dooley
Contact email
Sponsor organisation
InterVene Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 11 days
Research summary
InterVene Inc., have developed a new device, the Recana Thrombectomy Catheter System, which is designed to treat chronic blockages and obstructions in veins that can develop as a result of deep vein thrombosis (DVT) and chronic venous insufficiency (CVI) or venous stent stenosis. These conditions often lead to serious long-term complications, such as swelling, pain, and difficulty with blood flow in affected areas.
This technology helps restore proper blood flow by breaking down and clearing hardened clots, scar tissue, and blockages that can form inside veins or around venous stents. It also addresses problems like re-narrowing (restenosis) in previously treated veins and removes stubborn tissue and web-like obstructions. By targeting these chronic issues, the Recana device offers a new option for improving vein health and reducing symptoms in patients with these challenging conditions.
This clinical study will be a prospective, non-randomised, first in human feasibility study to evaluate the safety and performance of the Recana Thrombectomy Catheter System for the treatment of patients with symptomatic post-thrombotic venous inflow/outflow obstruction. Up to 20 patients with symptomatic post-thrombotic venous inflow/outflow obstruction, who meet the inclusion/exclusion criteria will be enrolled and undergo the procedure with the Recana Thrombectomy Catheter System.
The study will be carried out at Guy's and Thomas' Hospital (UK). The study will be wholly funded by the manufacturer InterVene Inc.
This technology represents a breakthrough approach to treating complex venous conditions, aiming to improve patient outcomes by reducing vein wall inflammation, preventing fibrosis, and ultimately lowering the incidence of post-thrombotic complications. It is hoped that the minimally invasive endovascular thrombectomy with the Recana Thrombectomy Catheter System will alleviate the debilitating pain, oedema, ulceration and other aspects of chronic venous incompetence.
REC name
North of Scotland Research Ethics Committee 1
REC reference
25/NS/0069
Date of REC Opinion
18 Jul 2025
REC opinion
Further Information Favourable Opinion