UnknownNot Applicable

Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)

France, Germany, Netherlands230 participantsStarted 2022-09-30

Plain-language summary

The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.

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 Angio-SealTM VIP VCD
. Puncture site located at the femoral artery (i.e., between the inguinal ligament and the bifurcation of the superficial femoral and profunda femoris arteries)
. Angio-SealTM VIP VCD deployed as per instruction for use by a trained operator

Exclusion criteria

. Repuncture of the femoral artery within 90 days at the same access site
. Lumen diameter of femoral artery \< 4 mm
. Patients with clinically significant peripheral vascular disease at the puncture site (luminal narrowing of \>40% within 5 mm of the puncture site)
. Puncture site at or distal to the bifurcation of the superficial femoral and profunda femoris artery

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: Successful puncture site haemostasis

Timeframe: 6 hours post-procedure

Safety: freedom from major complications of the access site limb

Timeframe: 6 hours post-procedure

Trial details

NCT IDNCT05335525

SponsorTerumo Europe N.V.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-05

Contact for this trial

Evelyne Vicca

+32 16 381284 evelyne.vicca@terumo-europe.com

View on ClinicalTrials.gov More Vascular Closure trials