NCT06866756 Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon
| NCT ID | NCT06866756 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Andres Iñiguez Romo |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 479 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 479 participants in total. It began in 2021-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients with De novo lesion and in stent reestenosis. Exclusion Criteria: * The patient is not a candidate for balloon treatment.
Contact & Investigator
Victor A Jimenez Diaz, MD, MPH
PRINCIPAL INVESTIGATOR
Servicio Galego de Saude. Hospital Álvaro Cunqueiro
Frequently Asked Questions
Who can join the NCT06866756 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06866756 currently recruiting?
Yes, NCT06866756 is actively recruiting participants. Contact the research team at victor.alfonso.jimenez.diaz@sergas.es for enrollment information.
Where is the NCT06866756 trial being conducted?
This trial is being conducted at Vigo, Spain.
Who is sponsoring the NCT06866756 clinical trial?
NCT06866756 is sponsored by Andres Iñiguez Romo. The principal investigator is Victor A Jimenez Diaz, MD, MPH at Servicio Galego de Saude. Hospital Álvaro Cunqueiro. The trial plans to enroll 479 participants.