Clinical trial NCT06866756: Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon
Official title: Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Arterial Disease (CAD)
Keywords: DCB
Drug Coated Balloon
Drug eluting balloon
percutaneous coronary intervention
PCI
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with coronary artery disease eligible for percutaneous coronary intervention with a balloon

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.

Primary outcomes:
measure: Target lesions revascularization
timeFrame: 5 years
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 5 years
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Pontevedra
Study officials:
affiliation: Servicio Galego de Saude. Hospital Álvaro Cunqueiro
name: Victor A Jimenez Diaz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio Galego de Saude. Hospital Álvaro Cunqueiro
name: Andres Iñiguez Romo, MD, PhD
role: STUDY_CHAIR
References: