Angiographic Control Vs. Ischemia-driven Management of Patients Treated with PCI on Left Main with Drug-eluting Stents

Summary

The present study aims to compare a planned angiographic control (PAC) follow-up strategy vs. conservative management for patients treated with drug-eluting stents on unprotected left main artery in a prospective, randomized setting. PAC will be performed by coronary computed tomography (CCT), to avoid the limitations of the invasive coronary angiography which is usually employed to perform PAC. The superiority of a PAC-based approach will be tested on a hard clinical end-point such as the incidence of major adverse cardiovascular events. The investigators will also assess the performance of CCT as a tool to perform PAC.

Conditions

• Acute Coronary Syndrome
• Stable Chronic Angina
• Coronary Artery Disease
• Left Main Coronary Artery Disease

Interventions

DIAGNOSTIC_TEST

coronary computed tomography

patients randomized in this arm will perform computed coronary tomography 6 months after the index percutaneous revascularization on unprotected left main artery

Sponsors & Collaborators

• Università degli Studi di Ferrara

  collaborator OTHER

• Ospedale San Luigi Gonzaga, Orbassano

  collaborator UNKNOWN

• Ospedale Santa Croce-Carle Cuneo

  collaborator OTHER

• Azienda USL Reggio Emilia - IRCCS

  collaborator OTHER_GOV

• AUSL Romagna Rimini

  collaborator OTHER

• University of Ferrara Department of Life Sciences and Biotechnology

  collaborator UNKNOWN

• A.O.U. Città della Salute e della Scienza

  lead OTHER

Principal Investigators

• Fabrizio D'Ascenzo, MD · A.O.U. Città della Salute e della Scienza

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-11

Primary Completion

2024-09-03

Completion

2024-09-03

Countries

• Italy

Study Locations