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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 479 (estimated) |
| Sponsor | Fundacin Biomedica Galicia Sur Academic / other |
| Locations | 1 site (Vigo, Pontevedra) |
| Status | Recruiting |
| Started | September 1, 2021 |
| Main results expected | September 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 22, 2025 |
| Trial ID | NCT06866756 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
- Principal investigator: Victor A Jimenez Diaz, MD, MPH — Servicio Galego de Saude. Hospital Álvaro Cunqueiro
- Study coordinator: Víctor A Jiménez DÍaz, MD, MPH
- Email: victor.alfonso.jimenez.diaz@sergas.es
- Phone: +34986825564
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.