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Which access route for heart catheterization causes fewer bleeding complications?

NCT ID NCT04077762

Disease control Sponsor: Minneapolis Heart Institute Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial compares two ways to access the blood vessels during cardiac catheterization: through the wrist (radial access) versus through the groin using modern techniques (femoral access). The goal is to see which approach leads to fewer bleeding events and access-site complications in patients undergoing this procedure for ischemic symptoms or planned PCI. Participants are randomly assigned to one of the two approaches, and the femoral group is further randomized to use either an 18 or 21 gauge needle. The study will help determine the safest and most effective access method for routine cardiac catheterization.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radial access versus state-of-the-art femoral access (with 18 or 21 gauge needles) as vascular access procedures for cardiac catheterization
What this could lead to
If radial access proves safer, it could become the preferred standard for cardiac catheterization, reducing bleeding and vascular complications in many patients.
What could go wrong
The trial is open-label, so results may be influenced by operator skill and experience. Femoral access with modern techniques might already be as safe as radial access, limiting potential differences.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3,266 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2019

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years and older * Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI * Has provided informed consent and agrees to participate * Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access Exclusion Criteria: * Primary PCI for STEMI * Planned right heart catheterization * Valvular heart disease requiring valve surgery within 30 days after the index procedure * Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one) * Peripheral arterial disease prohibiting vascular access * Presence of bilateral internal mammary artery coronary bypass grafts * International normalized ratio ≥1.5 while treated with oral vitamin K antagonists (i.e. warfarin) Receipt of oral factor Xa or IIa inhibitors ≤24 h before procedure * Planned staged PCI within 30 days after index procedure. * Any planned surgeries within 30 days after index procedure * Planned dual arterial access (for example for chronic total occlusion PCI) * Coexisting conditions that limit life expectancy to less than 30 days * Positive pregnancy test

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction Patient Satisfaction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Patient satisfaction Vascular access complication

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Henry Ford Hospital

    NOT_YET_RECRUITING

    Detroit, Michigan, 48202, United States

  • Joseph Maxwell Cleland Atlanta VA Medical Center

    RECRUITING

    Decatur, Georgia, 30033, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Minneapolis Heart Institute Foundation

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Oklahoma Heart Hospital

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • San Francisco VA Medical Center

    RECRUITING

    San Francisco, California, 94121, United States

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