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Heart device essential pro passes safety check in Real-World study

NCT ID NCT05292092

Disease control Sponsor: Fundación EPIC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tracked 161 patients with coronary artery disease who were treated with the Essential Pro device in routine hospital practice. The goal was to confirm the device's safety and performance, such as freedom from heart attack or repeat procedures. Results support its continued use for opening blocked heart arteries.

What this could mean

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

Active substance
Essential Pro (a drug-coated balloon or stent device for opening blocked heart arteries)
What this could lead to
If results confirm safety and performance, it supports continued use of Essential Pro as a routine option for treating blocked heart arteries.
What could go wrong
This is a post-market observational study, not a randomized trial, so it cannot prove the device is better than alternatives. Results may not apply to all patients.

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.

Participants

161 people

The number who actually took part.

Started

Sep 2022

Finished

Jan 2026

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.

Who is studied

Patients treated with Essential Pro according to routine hospital practice and following instructions for use

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: * Patient treated with Essential Pro according to routine hospital practice and following instructions for use * Informed consent signed Exclusion Criteria: • Not meet inclusion criteria

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Conditions

The condition(s) this trial relates to.

coronary artery disorder myocardial ischemia

As listed by the trial registrant

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

Coronary artery disease (CAD) Ischemic heart disease

Contacts and locations

Locations

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Punta de Europa

    Algeciras, 11207, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Regional de Malaga

    Málaga, 29010, Spain

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera, 11407, Spain

  • Hospital Universitario de Leon

    León, 24080, Spain

  • Hospital Universitario de Puerto Real

    Puerto Real, 11510, Spain

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