WRAPSODY First
Research type
Research Study
Full title
Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Venous Outflow Circuit Obstruction In Hemodialysis Patients.
IRAS ID
248920
Contact name
James A Gilbert
Contact email
Sponsor organisation
Merit Medical Systems Inc.
Clinicaltrials.gov Identifier
CIV-GR-18-06-024444, EUDAMED
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
The purpose of this study is to evaluate small number of patients to collect initial information on the safety and effectiveness of a new medical device for treatment of blocked or narrowed veins in the arm and upper chest of patients who are receiving hemodialysis treatment. The investigational device is called the WRAPSODY Endovascular Stent Graft. The WRAPSODY Endovascular Stent Graft is a medical device that is placed inside a vein to help keep it open. It is a small tube-shaped device made of metal and covered with a material that helps to prevent new formation of tissue, to prevent the vein from narrowing in the same area again. Subject eligibility will be determined by reviewing patient medical history, current health status and dialysis treatments. Approximately 15 subjects meeting the study entry criteria will be enrolled. Prior to stent placement, the doctor will perform a standard procedure called Percutaneous Transluminal Angioplasty (PTA) in which a medical balloon will be inserted into the patient’s vein through a catheter. The balloon will be inflated in order to widen the vein and then removed. The WRAPSODY stent graft will then be inserted into the patient’s vein by a delivery catheter. To ensure that the stent graft opens completely another medical balloon will be inserted into the stent graft and inflated. The doctor will then remove the balloon and catheter, and the stent graft will remain in in the patient’s vein. The whole procedure will be performed under local anesthesia. Post study procedure, subjects will have planned follow-up visits at 30 days (± 7 days), 3, 6 and 12 months (± 4 weeks at each timepoint), and additional visits as referred by the subject’s dialysis facility.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
18/YH/0262
Date of REC Opinion
16 Aug 2018
REC opinion
Further Information Favourable Opinion