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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Arterial Disease (CAD)

• Study Type: Observational
• Enrollment (Estimated): 479

Contacts and Locations

• Study Contact: Name: Víctor A Jiménez Díaz, MD, MPH; Phone Number: +34986825564; Email: victor.alfonso.jimenez.diaz@sergas.es
• Study Contact Backup: Name: Andres Iñiguez Romo, MD, PhD; Phone Number: +34986825564; Email: andres.iniguez.romo@sergas.es

Study Locations

• Spain
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Recruiting
      • Hospital Alvaro Cunqueiro
      • Contact: Víctor A Jiménez Díaz, MD, MPH; Phone Number: +34986825564; Email: victor.alfonso.jimenez.diaz@sergas.es
      • Principal Investigator: Victor A Jimenez Diaz, MD, MPH
      • Contact: Andres Iñiguez Romo, MD, PhD; Phone Number: +34986825564; Email: andres.iniguez.romo@sergas.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient with coronary artery disease eligible for percutaneous coronary intervention with a balloon

Description

Inclusion Criteria:

• Patients with De novo lesion and in stent reestenosis.

Exclusion Criteria:

• The patient is not a candidate for balloon treatment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sirolimus-Coated Balloon; Patients with coronary artery disease treated with Sirolimus-Coated Balloon
Paclitaxel-Coated Balloon; Patients with coronary artery disease treated with Paclitaxel-Coated Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesions revascularization	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	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events	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.	5 years

Collaborators and Investigators

• Sponsor: Andres Iñiguez Romo
• Investigators: Principal Investigator: Victor A Jimenez Diaz, MD, MPH, Servicio Galego de Saude. Hospital Álvaro Cunqueiro; Study Chair: Andres Iñiguez Romo, MD, PhD, Servicio Galego de Saude. Hospital Álvaro Cunqueiro

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: PCI; percutaneous coronary intervention; Drug Coated Balloon; DCB; Drug eluting balloon
• Other Study ID Numbers: CAR-BAL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data used to support the findings of this study are available from the corresponding author upon reasonable request.
• IPD Sharing Time Frame: Deidentified individual participant data and supporting documents will be available beginning 6 months after publication of the primary results and for a period of 5 years. Availability beyond this period will be considered upon request.
• IPD Sharing Access Criteria: Qualified researchers may request access to the deidentified IPD and supporting information for scientifically sound proposals. Access will be granted after approval by the principal investigator and the signing of a data use agreement. Data will be shared via secure transfer.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No