Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon.

Summary

Significant lesions in small coronary arteries are frequently found (35%-50%) in patients with coronary artery disease. Independently of the type of coronary angioplasty the restenosis and the need for repeat revascularization remains the main limitation, representing a challenging problem even in the DES (drug eluting stent) era. Recently has been developed drug eluting balloons (DEBs), which have been successfully tested in small series on in-stent restenosis, but few evidence is available in the context of small vessels disease.

The current study has been designed to know, in one hand, the clinical efficacy of the Drug elluting balloon IN.PACT FALCON and, in other hand, the effectiveness, and the cost-effectiveness incremental analysis of DEBs (IN.PACT FALCON vs. DES ( RESOLUTE INTEGRITY) in patients with de novo lesions in small vessels.

Conditions

• Coronary Disease

Interventions

DEVICE

Drug elluting Balloon (DEB)

Percutaneous transluminal coronary angioplasty with drug elluting ballon and Bare metal stent for rescue.

DEVICE

Drug elluting coronary stent (DES)

Percutaneous transluminal coronary angioplasty (PTCA) with stent

Sponsors & Collaborators

• Andres Iñiguez Romo, MD, PhD

  lead OTHER_GOV

Principal Investigators

• Andres Iñiguez Romo, MD,PHD · Hospital Universitario Alvaro Cunqueiro

• Victor A. Jimenez Diaz, MSC · Hospital Universitario Alvaro Cunqueiro

• Pablo M Juan Salvadores, Pharma; MPH · Hospital Universitario Alvaro Cunqueiro

• Jose M. Hernández García., MD · Hospital Virgen de la Victoria

• Eduardo Molina Navarro, MD · Hospital Virgen de las Nieves

• Francisco Bosa Ojeda, MD · Complejo Hospitalario Universitario de Canarias

• Armando Pérez de Prado, MD · Hospital Universitario de Leon

• Fernando Lozano Ruiz-Poveda, MD · Hospital Universitario de Ciudad Real

• Cristobal A. Urbano Carrillo · Hospital Clínico Universitario Carlos Haya

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2017-05-31

Completion

2018-04-06

Countries

• Spain

Study Locations