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

NCT04144881 | Completed DMC

• 1 other identifier: PULSE-ULM
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACE)

  composite and mutual exclusive end point including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina (UA), stent thrombosis

  18 months after the index revascularization

Secondary Outcomes (5)

• Target lesion revascularization (TLR)

  18 months after the index revascularization

• All cause death

  within 18 months from the index revascularization

• stent thrombosis

  within 18 months from the index revascularization

• CV death

  within 18 months from the index revascularization

• Myocardial infarction

  within 18 months from the index revascularization

Other Outcomes (5)

• AKI

  2 days after CCT in the experimental arm

• Renal function impairment

  18 months after the index revascularization

• Overall bleedings

  18 months after the index revascularization

Study Arms (2)

coronary computed tomography

EXPERIMENTAL

Diagnostic Test: coronary computed tomography

conservative (ischemia-guided) management

NO INTERVENTION

Interventions

coronary computed tomography DIAGNOSTIC_TEST

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

coronary computed tomography

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cardiogenic shock
• Refusal or inability to provide informed consent

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead
• Università degli Studi di Ferrara: collaborator
• Ospedale San Luigi Gonzaga, Orbassano: collaborator
• Ospedale Santa Croce-Carle Cuneo: collaborator
• Azienda USL Reggio Emilia - IRCCS: collaborator
• AUSL Romagna Rimini: collaborator
• University of Ferrara Department of Life Sciences and Biotechnology: collaborator

Study Sites (3)

AOU Città della Salute e della Scienza di Torino

Torino, Italy, 10126, Italy

Location

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, 44124, Italy

Location

Ospedale San Luigi Gonzaga, Orbassano

Orbassano, 10043, Italy

Location

Related Publications (22)

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  PMID: 40886174 DERIVED

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  PMID: 33122421 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina, Stable; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Fabrizio D'Ascenzo, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: October 11, 2019
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)