CompletedNot Applicable

Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study

Belgium, France, Germany230 participantsStarted 2021-12-27

Plain-language summary

The study aims to further demonstrate the safety and effectiveness of the FemoSeal™ VCS in achieving hemostasis following percutaneous endovascular procedures performed via the common femoral artery (CFA) access site. This study is conducted in real-world subjects according to the FemoSeal™ VCS instruction for use (IFU), as part of the study device post-market clinical follow up surveillance plan and prospective clinical evidence collection.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject is ≥ 18 years old
. Subject is willing and able to complete the follow-up requirements
. Subject has the mental capacity (i.e. does not require the use of a Legally Authorized Representative) to sign the study Informed Consent Form (ICF)
. Patient undergoing diagnostic or interventional endovascular procedure compatible with the use of FemoSeal™ VCS
. Puncture site located at the CFA (i.e. between the inferior epigastric artery and the bifurcation of the superficial and profunda femoral arteries)
. FemoSeal™ VCS deployed as per instruction for use by a trained operator on arteriotomy where sheaths or devices of ≤7F were used, following a femoral artery angiogram

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effectiveness endpoint: Successful puncture site haemostasis

Timeframe: within 6 hours post procedure

Safety endpoint: Freedom from major complications

Timeframe: within 6 hours post procedure

Trial details

NCT IDNCT05027698

SponsorTerumo Europe N.V.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-07-04

View on ClinicalTrials.gov More Vascular Closure trials