CompletedNot Applicable

Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study

Germany600 participantsStarted 2014-02

Plain-language summary

FERARI is a single centre observational study comparing patients undergoing PCI either using radial compression devices or femoral closure devices at the corresponding access site. First primary outcomes consist of the occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems Second primary outcomes consist of the occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR) during 30 days and 12 months of follow-up.

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: * Informed consent about the study * Elective PCI with following indications: Stable coronary artery disease, proven myocardial ischemia; cardiac arrhythmia; syncope; Unstable AP defined as NSTEMI but without cardiac troponin elevation; NSTEMI; STEMI * patient eligible for coronary angiography and both radial and femoral PCI * requirement of using a vascular closure device (without contraindications) Exclusion Criteria: * inability to understand and sign the informed consent term * pregnancy * less 18 years of age * single diagnostic coronary angiography * active or high bleeding risk (thrombocytopenia \<50,000/µl) * femoral approach and PCI without using a vascular closure device * other conditions hampering involvement in the study

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

Vascular complications at the arterial access site

Timeframe: 30 days

Adverse cardiac events

Timeframe: 30 days

Adverse cardiac events

Timeframe: 12 months

Trial details

NCT IDNCT02455661

SponsorUniversitätsmedizin Mannheim

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05

View on ClinicalTrials.gov More Arterial Closure Device trials