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Heart artery showdown: one device vs. custom toolkit for stent success

NCT ID NCT07105930

Disease control Sponsor: IHF GmbH - Institut für Herzinfarktforschung 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if using a single device (orbital atherectomy) to sand away calcium in heart arteries works as well as letting doctors choose from several methods based on each patient's calcium type. About 310 adults with severely calcified arteries will be randomly assigned to one approach. The goal is to see how well the stent expands after treatment.

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 310 people

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

Started

Oct 2025

Expected to finish

Mar 2027

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 * Chronic coronary syndrome with a clinical indication for percutaneous coronary intervention of a severely calcified lesion as defined by coronary computer tomography (CT; Agatston Score of target lesion ≥453 OR Calcium Arc \>270°). The determination of calcification in the target lesion is based on native and contrast enhanced CT scans that are conducted as per clinical guidelines. The CT images must not be older than 6 months at the time of patient enrollment. * Signed informed consent * The patient is an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy Exclusion Criteria: * Acute ST-Elevation Acute Coronary Syndrome (STE-ACS) within 48 hours * Cardiogenic shock * Chronic total occlusion of the target lesion * Glomerular filtration rate \< 30 ml/min/1.73 m2 * Known presence, at the time of enrollment, of any contraindications listed in the Instructions for Use (IFU) of the investigational device: * The OCT (optical coherence tomography) imaging catheter cannot cross * The wire or imaging catheter cannot cross * The target lesion is within a bypass graft or stent * The patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy. * The patient has angiographic evidence of thrombus * The patient has only one open coronary vessel * The patient has angiographic evidence of flow reducing dissection at the treatment site * The patient has a known hypersensitivity to egg-, soy-, or peanut protein or to any of the active substances or excipients of the ViperSlide™ lubricant * Pregnancy (assessed by clinical routine testing) * Participation in another interventional clinical trial

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

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

Orbital atherectomy

How to take part

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

  1. The places running it

    1 site. 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

  • Universitäres Herz - und Gefäßzentrum, Unversitätsklinikum Frankfurt

    RECRUITING

    Frankfurt, Germany

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