Comparing two types of drug-coated balloons for heart artery treatment
Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon
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 |
|---|---|
| Enrollment | 479 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacin Biomedica Galicia Sur Academic / other |
| Locations | 1 site (Vigo, Pontevedra) |
| Trial ID | NCT06866756 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with de novo lesions or in-stent restenosis who are eligible for balloon treatment.
Not a fit: Patients who are not candidates for balloon treatment will not benefit from this study.
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 performed: Previous studies have shown promising results with drug-coated balloons, but this specific comparison is less explored, making it a novel approach.
Eligibility criteria
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 this trial is running
Vigo, Pontevedra
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.