Safety and Performance Study of Large Hole Vascular Closure Device FIV (NCT03423602) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance Study of Large Hole Vascular Closure Device FIV
Germany, Ireland75 participantsStarted 2017-10-12
Plain-language summary
The purpose of this Clinical Investigation Plan (CIP) is to:
1. Confirm the safety and performance of the PerQseal® large hole closure system.
2. To expand its indications of use to include common femoral arteriotomies created with 12 to 20 F sheaths in patients undergoing endovascular procedures.
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:
* Over 18 years of age.
* Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
* Clinically indicated for an endovascular procedure using a common femoral arteriotomy created by a 12 - 20 F sheath.
Exclusion Criteria:
* Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than six months.
* Evidence of systemic bacterial or cutaneous infection, including groin infection.
* Known bleeding diathesis, definite or potential coagulopathy, platelet count \< 100,000/μl or patients on long term anticoagulants with an INR greater than 1.2 at time of procedure or known type II heparin-induced thrombocytopenia.
* Severe; claudication or peripheral vascular disease (e.g. Rutherford category 3 or greater or ABI \< 0.5), documented untreated iliac artery diameter stenosis \> 50% or previous bypass surgery/stent placement in the common femoral artery of ipsilateral limb.
* Known allergy to any of the materials used in the PerQseal®.
* Subject has undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral target leg.
* Patients that have undergone a percutaneous procedure in the ipsilateral leg, within the previous 30 days.
* Patients that have undergone a percutaneous procedure using an absorbable intravascular closure device for haemostasis…
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.