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

NCT ID: NCT06866756

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 479 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2026-12-31

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.

Conditions

Coronary Arterial Disease (CAD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Sirolimus-Coated Balloon

Patients with coronary artery disease treated with Sirolimus-Coated Balloon

No interventions assigned to this group

Paclitaxel-Coated Balloon

Patients with coronary artery disease treated with Paclitaxel-Coated Balloon

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with De novo lesion and in stent reestenosis.

Exclusion Criteria

• The patient is not a candidate for balloon treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andres Iñiguez Romo

OTHER

Sponsor Role: lead

Responsible Party

Andres Iñiguez Romo

Head of Cardiology Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Victor A Jimenez Diaz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Servicio Galego de Saude. Hospital Álvaro Cunqueiro

Andres Iñiguez Romo, MD, PhD

Role: STUDY_CHAIR

Servicio Galego de Saude. Hospital Álvaro Cunqueiro

Locations

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Víctor A Jiménez DÍaz, MD, MPH

Role: CONTACT

victor.alfonso.jimenez.diaz@sergas.es

+34986825564

Andrés Iñiguez Romo, MD, PhD

Role: CONTACT

andres.iniguez.romo@sergas.es

+34986825564

Facility Contacts

Víctor A Jiménez Díaz, MD, MPH

Role: primary

victor.alfonso.jimenez.diaz@sergas.es

+34986825564

Andres Iñiguez Romo, MD, PhD

Role: backup

andres.iniguez.romo@sergas.es

+34986825564

Other Identifiers

CAR-BAL-001

Identifier Type: -

Identifier Source: org_study_id