Condition: Coronary Arterial Disease (CAD) · Sponsor: Andres Iñiguez Romo
Cardiovascular disease (CVD) is the leading cause of mortality worldwide, with a significant burden in low- and middle-income countries. Acute coronary syndrome (ACS) is often the first clinical manifestation of CVD, representing a major cause of morbidity and mortality. Global variations exist in revascularization rates and long-term mortality following ACS. It is estimated that 12% of disability-adjusted life years are lost annually due to CVD. Drug-coated balloons (DCB) constitute a promising technology to overcome few disadvantages of current latest generation of drug-eluting stents (DES). The safety of these devices has been proven previously. However, there is few data regarding its efficacy in a broad spectrum of clinical setting and patient population. Hypothesis: The sirolimus-coated drug-eluting balloon demonstrates comparable safety and efficacy to the paclitaxel-coated balloon in patients undergoing angioplasty for coronary artery disease. Primary Objective: To assess the safety and efficacy of paclitaxel- vs. sirolimus-coated drug-eluting balloon over 12 months in patients undergoing coronary angioplasty for in-stent restenosis or small-vessel stenosis. Secondary Objectives: To compare the efficacy (freedom from target vessel failure) of both balloons at 12 months. To evaluate the safety of paclitaxel- vs. sirolimus-coated balloon in coronary revascularization at 12 months. Study Design: Study Type: Prospective, single-center, analytical cohort study. P…
This description comes directly from the study's public registry record.
Víctor A Jiménez DÍaz, MD, MPH · +34986825564 · victor.alfonso.jimenez.diaz@sergas.es
Andrés Iñiguez Romo, MD, PhD · +34986825564 · andres.iniguez.romo@sergas.es
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| Hospital Álvaro Cunqueiro | Vigo, Pontevedra, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06866756