Clinical trial Recruiting at 1 site Observational Ages 18 and up

Comparing two types of drug-coated balloons for heart artery treatment

Official title: Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon

Run by Fundacin Biomedica Galicia Sur · NCT06866756 · Data updated 2026-11-12

This study tests whether sirolimus-coated balloons work better and are safer than paclitaxel-coated balloons for treating heart artery blockages in patients undergoing angioplasty.

More Coronary Arterial Disease (CAD) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment479 (estimated)
SponsorFundacin Biomedica Galicia Sur
Academic / other
Locations1 site (Vigo, Pontevedra)
StatusRecruiting
StartedSeptember 1, 2021
Main results expectedSeptember 1, 2026
Study endsDecember 31, 2026
Registry record updatedAugust 22, 2025
Trial IDNCT06866756 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients with de novo lesions or in-stent restenosis who are eligible for balloon treatment.

Probably not a fit

Patients who are not candidates for balloon treatment will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the safety and efficacy of sirolimus-coated drug-eluting balloons compared to paclitaxel-coated balloons in patients undergoing angioplasty for coronary artery disease. It focuses on patients with de novo lesions and in-stent restenosis, addressing the need for effective revascularization methods in the context of cardiovascular disease. The study will gather data on outcomes related to the use of these two types of drug-coated balloons in a real-world clinical setting.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with coronary artery disease.

How similar studies have gone: Previous studies have shown promising results with drug-coated balloons, but this specific comparison is less explored, making it a novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients with De novo lesion and in stent reestenosis.

Exclusion Criteria:

* The patient is not a candidate for balloon treatment.

Where it's running

  • Hospital Álvaro Cunqueiro
    Vigo, Pontevedra, Spain
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Red grape juice and metabolism in men with coronary disease

    Researchers will test whether daily red grape juice changes the blood metabolite profile in men with chronic coronary artery disease.

    Recruiting University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07777341

  • Edoxaban vs. Apixaban in AF with CAD: Net Benefit

    This trial tests whether edoxaban-based therapy provides a similar or better overall benefit than apixaban-based therapy for stroke prevention and major bleeding in adults with atrial fibrillation and coronary artery disease.

    Recruiting Phase 4 Samsung Medical Center · Seoul · NCT07753200

  • Revascularization of Calcified Coronary Arteries

    This study tests whether measuring blood flow and pressure before and after ballooning or stenting of calcified coronary arteries can help predict how well the procedure will work for adults with heart disease.

    Recruiting Aalborg University Hospital · Aalborg · NCT07724184

  • OPN Balloon Use for Recanalization of Calcified Coronary Lesions

    This registry tests how the SIS-OPN balloon is used in real-world patients with calcified coronary disease who have undergone PCI in North America.

    Recruiting Minneapolis Heart Institute Foundation · Minneapolis, Minnesota · NCT07646444

  • Pulse IVL to open calcified coronary vessels in CAD

    A small, early feasibility study tests the Pulse Intravascular Lithotripsy system in adults with coronary artery disease to see if it can safely open calcified arteries and improve vessel compliance.

    Recruiting at 4 sites Amplitude Vascular Systems, Inc. · Sydney, New South Wales and 3 other locations · NCT07510438

  • Crystalline sirolimus-coated balloon for treating coronary artery disease

    This tests whether a crystalline sirolimus-coated balloon is safe and effective for adults having percutaneous coronary intervention for coronary artery blockages or in-stent restenosis.

    Recruiting Fundación Interhospitalaria para la Investigación Cardiovascular FIC · Vigo, Pontevedra · NCT07444957

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.