CompletedNot Applicable

Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With CFA Disease

United States200 participantsStarted 2020-08-20

Plain-language summary

To study the patient characteristics and outcomes associated with the real-world use of manual compression vs. vascular closure devices (VCDs) after common femoral artery (CFA) percutaneous access for coronary and endovascular interventions. An institutional procedural database, based on electronic medical record information will be abstracted to collect this information.

Who can participate

Age range

18 Years – 100 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

. 5, 6 or 7 Fr access within the CFA
. ACT \< 300 seconds
. Age 18 - 90 years old
. Severe common femoral arterial disease Percent stenosis \> 50, which will be core-lab adjudicated

Exclusion criteria

. Ipsilateral CFA access within 30 days preceding or subsequent to the index case
. Prior ipsilateral closure device use, other than VASCADE
. High bleeding risk ACT \> 300 or \> 250 with IIb/IIIa inhibitor Plt \< 50K INR \> 1.7 on the day of procedure Inherent coagulopathy NOAC, warfarin, or lovenox administered within 24 hours of the procedure

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

Adequate hemostasis - (efficacy)

Timeframe: within an hour immediately after procedure

No complications after procedure - (safety)

Timeframe: early (48 hours)

No complications after procedure - (safety)

Timeframe: late (30-day)

Trial details

NCT IDNCT04745624

SponsorYale University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-01

View on ClinicalTrials.gov More Common Femoral Artery Stenosis trials