Angiographic Control Vs. Ischemia-driven Management of Patients Treated with PCI on Left Main with Drug-eluting Stents
CompletedNot applicableNCT04144881
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Angiographic Control Vs. Ischemia-driven Management of Patients Undergoing Percutaneous Revascularization of the Unprotected Left Main Coronary Artery with Second-generation Drug Eluting Stents: the PULSE Trial
- Conditions
- Acute Coronary Syndrome
- Stable Chronic Angina
- Coronary Artery Disease
- Left Main Coronary Artery Disease
- Interventions
- Diagnostic test: coronary computed tomography
- Sponsor
- A.O.U. Città della Salute e della Scienza
- Collaborators
- Università degli Studi di Ferrara; San Luigi Gonzaga Hospital; Ospedale Santa Croce-Carle Cuneo; Azienda USL Reggio Emilia - IRCCS; AUSL Romagna Rimini; University of Ferrara Department of Life Sciences and Biotechnology
- Start date
- 2019-10-11
- Primary completion
- 2024-09-03
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Patients with ULM disease treated by PCI with DES-II with the following inclusion criteria: * Age 18-85. * Glomerular filtration rate \> 30 ml/min Indication to percutaneous revascularization of ULM according to Syntax score (\< 33) or, in dubious cases, after Heart Team evaluation Exclusion Criteria: * Cardiogenic shock * Refusal or inability to provide informed consent
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04144881