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Active, not recruiting

NCT Number: NCT07817524

Clinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction (CROWN)

The objective of this study is to evaluate the best treatment strategy in patients with critical coronary artery disease and severe left ventricular dysfunction.

In details, main goal of the study is to compare the clinical outcomes of patients with critical coronary artery disease and severe left ventricular dysfunction undergoing surgical coronary artery bypass grafting with those of patients treated by percutaneous coronary intervention.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168, Italy

About this study

Despite CABG being increasingly performed in patients with reduced EF, the literature lacks of data directly comparing the clinical outcomes of surgical versus percutaneous revascularization in patients with left ventricular dysfunction.

The goal of this study is to compare the clinical outcomes of patients with critical coronary artery disease and severe left ventricular dysfunction undergoing surgical coronary artery bypass grafting with those of patients treated by percutaneous coronary intervention (PCI).

All patients affected by coronary artery disease who underwent surgical treatment (coronary artery bypass grafting, CABG) or percutaneous treatment (percutaneous coronary intervention, PCI) between January 2019 and December 2023, and who meet the inclusion and exclusion criteria, will be included in the study. Each patient will be enrolled following an interview and the subsequent signing of the informed consent form. Data will then be recorded in a dedicated database. In detail, the following information will be collected: anamnestic data, description of the performed procedure, preoperative and postoperative laboratory test results, preoperative, intraoperative, and postoperative echocardiographic parameters (including follow-up visits up to 2 years after the procedure), length of stay in the Intensive Care Unit and in the general ward, and data regarding any intraoperative and postoperative complications (death, shock, pericardial effusion, stroke, myocardial infarction, need for postoperative PCI, rehospitalization, heart failure). All data recorded in the database are routinely collected for all patients undergoing this type of intervention, and no additional examinations will be performed on patients included in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years old;
  • Written informed consent;
  • Indication to CABG surgery (both "on-pump" and "off-pump") or to PCI;
  • Preoperative EF ≤35%.

Exclusion criteria

  • Inability to give written informed consent;
  • Emergency surgery;
  • Combined cardiac surgical procedures;
  • Previous cardiac surgery.

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: through study completion, an average of 1 year

    Number of patients who died for any cause after CABG or PCI

Secondary outcomes

  1. Mortality from cardiovascular causes

    Time frame: through study completion, an average of 1 year

    Number of patients who died for cardiovascolar causes after CABG or PCI

  2. Acute myocardial infarction

    Time frame: through study completion, an average of 1 year

    Number of patients who experienced myocardial infarction after CABG or PCI

  3. Rehospitalization from cardiovascular reasons

    Time frame: through study completion, an average of 1 year

    Number of patients who needed rehospitalization after being discharged

  4. Repeated revascularization

    Time frame: through study completion, an average of 1 year

    Number of patients who needed repeated revascularization after CABG or PCI

  5. Stroke

    Time frame: through study completion, an average of 1 year

    Number of patients who had stroke after CABG or PCI

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Clinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction: the CROWN Study.

Acronym: CROWN

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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