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New balloon treatment may shorten blood thinner use for heart patients

NCT ID NCT06321757

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Updated 2 times

Summary

This study is testing a paclitaxel-coated balloon to open small coronary arteries in people with heart disease who also have a high risk of bleeding. About 501 participants will receive the balloon treatment and then take blood thinners for either the standard duration or just 7 days. The goal is to see if the balloon works well and if a shorter course of blood thinners is safe.

What this could mean

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

Active substance
paclitaxel-coated balloon
What this could lead to
If successful, this could show that a drug-coated balloon with just 7 days of blood thinners is safe and effective for people with small heart arteries and high bleeding risk.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The short blood thinner regimen might still carry bleeding or clotting risks.

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

501 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Dec 2026

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.

Who is studied

drug-coated ballon therapy in real-world patients with small native vessel coronary artery disease

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: Patients with: * PCI with DCB on native arteries with diameters \< 3 mm. * Indication for PCI in acute coronary syndrome or chronic coronary syndrome or silent angina with an indication for PCI. syndrome or silent angina with an indication for PCI. * If previous lesion preparation was required after which angiographic residual lesion should not exist with diameter stenosis \> 30% or flow-limiting coronary dissections. * All antithrombotic therapies administered prior to the procedure are accepted. Still, they can be changed after the procedure. * Capacity to understand and sign the written informed consent. * If the patient has a high-bleeding risk defined by 1) PRECISE-DAPT SCORE ≥ 25 or 2) an indication for concomitant oral anticoagulation he can be included in the high- bleeding risk substudy as long as he does not meet the specific exclusion criteria. Exclusion Criteria: Patients with: * Concomitant lesions on vessels \> 3 mm in diameter in the same coronary territory. * PCI on in-stent restenoses. * PCI on culprit lesions of acute coronary syndrome with ST segment elevation. * Patients with an indication for PCI on additional non-culprit lesions of acute coronary syndrome with ST segment elevation may be included in the study, if only non-culprit lesions are considered for the study. * Life expectancy \<12 months * Pregnancy. * Participation in clinicaltrials. * Inability to give the written informed consent. * Specific exclusion criteria for the high-bleeding risk patient subgroup: * Past medical history of stent thrombosis. * Indication for dual antiplatelet therapy for a different reason.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary stenosis

As listed by the trial registrant

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

Coronary artery disease

Contacts and locations

Locations

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, 90146, Italy

  • Clinica Mediterranea

    Naples, 08122, Italy

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003, Spain

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010, Spain

  • Hospital General Universitario de Albacete

    Albacete, 02008, Spain

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital Universitario Clinico San Cecilio

    Granada, 18016, Spain

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital Universitario Y Politecnico La Fe

    Valencia, 46026, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Spain

  • Hospital Universitario de Cruces

    Barakaldo, 49803, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, 35010, Spain

  • Hospital Universitario de La Princesa

    Madrid, 28006, Spain

  • Hospital Universitario de Leon

    León, 24071, Spain

  • ULS Santa Maria

    Lisbon, Portugal

  • Ulslo-H.Santa Cruz

    Carnaxide, Portugal

  • University Hospital HM Montepríncipe

    Boadilla del Monte, 28660, Spain

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