BYV-PMCF
Research type
Research Study
Full title
Prospective, multicentre single-arm Post-Market Clinical Follow-up (PMCF) study to evaluate safety and performance of the BeYond Venous Self-Expanding Stent.
IRAS ID
296994
Contact name
Martin Schirling
Contact email
Sponsor organisation
Bentley InnoMed GmbH
Clinicaltrials.gov Identifier
German Clinical Trial Register (DRKS), DRKS00024063
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
The „BeYond Venous Self-Expanding Stent“ medical device used in this study is already certified as a medical device for the targeted treatment of symptomatic occlusion of the femoral or iliac vein.
The purpose of the study is to collect additional data on the performance and safety of the „BeYond Venous Self-Expanding Stent“ to increase knowledge about the treatment and contribute to improving treatment in the future.
The patient will be asked whether he wishes to participate in this study because it is planned to use the “BeYond Venous Self-Expanding Stent” as standard treatment for the symptomatic occlusion of the femoral or iliac vein.
The participation in this study should last a maximum of 24 months.
Data will be collected for the study during your treatment at the preliminary examination, at stent placement, before discharge and at follow-up appointments at 3, 6, 12 and 24 months.
This includes data from the physical examination, risk factors, concomitant diseases and medication. Blood values will also be recorded at the first appointment. For this purpose, about 13 ml of blood will be taken once.
In addition, a venogram will be performed at the first appointment to assess your veins and an ultrasound will be performed at all appointments to measure and visualise the blood flow. If blood flow needs to be restored (revascularisation) during a check-up, this will also be documented.
Furthermore, the physician will evaluate the success of the treatment on the basis of clinical evaluation sheets at several appointments.As with any medical device, new, previously unknown side effects may occur when using the "BeYond Venous Self-Expanding Stent”.
Therefore, the patient is asked to inform the study site staff of any complaints, illnesses or injuries that occur during the study. If these are serious, the study site staff will be informed immediately.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
21/YH/0279
Date of REC Opinion
6 Dec 2021
REC opinion
Further Information Favourable Opinion