Experience in Percutaneous Coronary Intervention with Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon

Recruiting

• Conditions: Coronary Arterial Disease (CAD)

• Registration Number: NCT06866756
• Lead Sponsor: Andres Iñiguez Romo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2025-02-26
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 479

Inclusion Criteria

• Patients with De novo lesion and in stent reestenosis.

Exclusion Criteria

• The patient is not a candidate for balloon treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesions revascularization	5 years	Rate of clinically driven target lesion revascularization (TLR) at 12 months, defined as any repeat percutaneous intervention or surgical bypass of the target lesion due to symptoms or objective evidence of ischemia

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	5 years	Incidence of Major Adverse Cardiovascular Events (MACE) at 5 years, defined as a composite of cardiovascular death, non-fatal myocardial infarction, and clinically driven lesion revascularization. Each event will be independently adjudicated by a clinical events committee.

Trial Locations

Locations (1)

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain