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

NCT06866756 | Recruiting DMC

• 1 other identifier: CAR-BAL-001
• Study Type: observational
• Target: 479
• Locations: 1 country
• Sites: 1

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)

Keywords

DCB; Drug Coated Balloon; Drug eluting balloon; percutaneous coronary intervention; PCI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Major adverse cardiovascular events

  5 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients with De novo lesion and in stent reestenosis.

You may not qualify if:

• The patient is not a candidate for balloon treatment.

Sponsors & Collaborators

• Andres Iñiguez Romo: lead

Study Sites (1)

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

Study Officials

• Victor A Jimenez Diaz, MD, MPH

  Servicio Galego de Saude. Hospital Álvaro Cunqueiro

  PRINCIPAL INVESTIGATOR

• Andres Iñiguez Romo, MD, PhD

  Servicio Galego de Saude. Hospital Álvaro Cunqueiro

  STUDY CHAIR

Central Study Contacts

Víctor A Jiménez DÍaz, MD, MPH

CONTACT

+34986825564; victor.alfonso.jimenez.diaz@sergas.es

Andrés Iñiguez Romo, MD, PhD

CONTACT

+34986825564; andres.iniguez.romo@sergas.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Cardiology Department

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 10, 2025
• Study Start: September 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

ES (1)