VIVID
Research type
Research Study
Full title
Venous stent for the Iliofemoral Vein Investigational clinical trial using the DUO™ Venous Stent System (VIVID)
IRAS ID
295250
Contact name
Stephen Black
Contact email
Sponsor organisation
Vesper Medical, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The VIVID clinical trial is studying an investigational device called the Vesper DUO Venous Stent System that includes both the DUO-HYBRID™ and DUO-EXTEND™ stents. These new venous stents are intended to endure the unique forces and motion that happen in deep veins and are designed to reduce the symptoms associated with Chronic Venous Insufficiency (CVI). They are being studied to treat iliac and common femoral vein blockages with or without a history of a blood clot in the legs.
VIVID is a prospective, multi-centre, single-arm, global IDE clinical trial evaluating the safety and efficacy of the Vesper DUO Venous Stent System in the treatment of iliofemoral occlusive disease. Up to 160 subjects will be enrolled at up to 45 U.S. and International clinical sites. Vesper Medical will follow patients for three years following enrolment to understand the clinical outcomes associated with the device.
In summary, stenting in chronic iliocaval obstruction is safe and effective. Excellent long-term results with respect to revascularization and symptom relief have been achieved. Recanalization to treat venous claudication with venous stents suggests the highest probability of success. The Vesper DUO™ Venous Stent System is a new purpose-built stent system that will be studied for use in treating iliac and common femoral vein obstructions.
REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0457
Date of REC Opinion
23 Jun 2021
REC opinion
Favourable Opinion