Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Arterial Disease (CAD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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. Population: Patients undergoing angioplasty with paclitaxel- or sirolimus-coated drug-eluting balloons according to standard clinical practice. Inclusion Criteria: Patients with De novo lesion and in stent reestenosis. Study Period: From September 2021 to September 2026 or until the required sample size is achieved. Study Importance: This study will provide comparative evidence on the use of paclitaxel- and sirolimus-coated DCBs in coronary revascularization. The findings may contribute to future clinical recommendations for the optimal use of DCBs in patients with coronary artery disease.
Primary outcome measures
- Target lesions revascularization [Time frame: 5 years]
Secondary outcome measures (1)
- Major adverse cardiovascular events [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Patients with De novo lesion and in stent reestenosis.
Exclusion criteria
- The patient is not a candidate for balloon treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Álvaro Cunqueiro — Vigo
Identifiers
NCT: NCT06866756 · CAR-BAL-001