UnknownNot Applicable

Efficacy and Safety of Hemostatic Methods in Distal Radial Artery Approach for Cardiac Catheterization

Mexico482 participantsStarted 2022-02-01

Plain-language summary

Comparison of PreludeSYNC distal and Modified Terumo Radial Band in patients with distal radial approach.

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: * Coronary artery disease including chronic coronary syndrome or acute coronary syndrome. * Cardiovascular disease that requires coronary angiography in its approach. Exclusion Criteria: * Cardiogenic shock. * Lesions in venous or arterial hemoducts. * Impossibility to provide informed consent. * Chronic kidney disease on hemodialysis through arteriovenous fistula at the same site where the approach is planned. * Severe chronic renal failure (GFR less than 30 ml/min/m2) * Patients diagnosed with cancer. * Patient with rheumatological and hematological pro-thrombotic disorders. * Non-hydrophilic radial introducer. * Failed cannulation of the radial artery with an introducer. * Successful trans-radial access that is crossed over to the femoral approach. * Patients with an interventional procedure using a radial approach in the previous 30 days.

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

To compare the incidence of proximal radial artery occlusion assessed by ultrasound and the incidence of hematoma/bleeding assessed clinically by EASY scale of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach.

Timeframe: 24 hours after the procedure. Patients with radial occlusion at 24 hours will be follow at 30 days.

Trial details

NCT IDNCT05966376

SponsorInstituto Nacional de Cardiologia Ignacio Chavez

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

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