Coronary Artery DiseaseCROWNNCT07817524
Clinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction (CROWN)
An observational study of Coronary Artery Disease and Left Ventricular Cardiac Dysfunction, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Left Ventricular Cardiac Dysfunction
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2025to 28 Feb 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients affected by coronary artery disease and severe left ventricular disfunction who underwent surgical treatment (coronary artery bypass grafting, CABG) or percutaneous treatment (percutaneous coronary intervention, PCI) between January 2019 and December 2023.
Who may be able to join
- Age >= 18 years old;
- Written informed consent;
- Indication to CABG surgery (both "on-pump" and "off-pump") or to PCI;
- Preoperative EF ≤35%.
Who cannot join
- Inability to give written informed consent;
- Emergency surgery;
- Combined cardiac surgical procedures;
- Previous cardiac surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction: the CROWN Study.
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.
Read the detailed description
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.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CABG | Patients with critical coronary artery disease and severe left ventricular disfunction treated with coronary artery bypass graft surgery | |
| PCI | Patients with critical coronary artery disease and severe left ventricular disfunction treated with percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Number of patients who died for any cause after CABG or PCI
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Mortality from cardiovascular causes
Number of patients who died for cardiovascolar causes after CABG or PCI
Measured: through study completion, an average of 1 year
Acute myocardial infarction
Number of patients who experienced myocardial infarction after CABG or PCI
Measured: through study completion, an average of 1 year
Rehospitalization from cardiovascular reasons
Number of patients who needed rehospitalization after being discharged
Measured: through study completion, an average of 1 year
Repeated revascularization
Number of patients who needed repeated revascularization after CABG or PCI
Measured: through study completion, an average of 1 year
Stroke
Number of patients who had stroke after CABG or PCI
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiariello Giovanni A, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817524
- Sponsor's protocol ID
- ID7753
- Acronym
- CROWN
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christiaan Vrints, Felicita Andreotti, Konstantinos C Koskinas, Xavier Rossello, Marianna Adamo, James Ainslie, Adrian Paul Banning, Andrzej Budaj, Ronny R Buechel, Giovanni Alfonso Chiariello, Alaide Chieffo, Ruxandra Maria Christodorescu, Christi Deaton, Torsten Doenst, Hywel W Jones, Vijay Kunadian, Julinda Mehilli, Milan Milojevic, Jan J Piek, Francesca Pugliese, Andrea Rubboli, Anne Grete Semb, Roxy Senior, Jurrien M ten Berg, Eric Van Belle, Emeline M Van Craenenbroeck, Rafael Vidal-Perez, Simon Winther, ESC Scientific Document Group , 2024 ESC Guidelines for the management of chronic coronary syndromes: Developed by the task force for the management of chronic coronary syndromes of the European Society of Cardiology (ESC) Endorsed by the European Association for Cardio-Thoracic Surgery (EACTS), European Heart Journal, Volume 45, Issue 36, 21 September 2024, Pages 3415-3537, https://doi.org/10.1093/eurheartj/ehae177
Morgan H, Nazir MS, Li Kam Wa ME, McCann GP, Greenwood JP, McDiarmid AK, Dodd M, Ryan M, Perera D, Chiribiri A. Prognostic impact of inducible ischaemia in ischaemic left ventricular dysfunction: the REVIVED-BCIS2 trial. Eur Heart J. 2025 Feb 3;46(5):487-490. doi: 10.1093/eurheartj/ehae844. No abstract available.
PubMed 39661477Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
PubMed 32227755Shaw LJ, Weintraub WS, Maron DJ, Hartigan PM, Hachamovitch R, Min JK, Dada M, Mancini GB, Hayes SW, O'Rourke RA, Spertus JA, Kostuk W, Gosselin G, Chaitman BR, Knudtson M, Friedman J, Slomka P, Germano G, Bates ER, Teo KK, Boden WE, Berman DS. Baseline stress myocardial perfusion imaging results and outcomes in patients with stable ischemic heart disease randomized to optimal medical therapy with or without percutaneous coronary intervention. Am Heart J. 2012 Aug;164(2):243-50. doi: 10.1016/j.ahj.2012.05.018.
PubMed 22877811Velazquez EJ, Lee KL, Deja MA, Jain A, Sopko G, Marchenko A, Ali IS, Pohost G, Gradinac S, Abraham WT, Yii M, Prabhakaran D, Szwed H, Ferrazzi P, Petrie MC, O'Connor CM, Panchavinnin P, She L, Bonow RO, Rankin GR, Jones RH, Rouleau JL; STICH Investigators. Coronary-artery bypass surgery in patients with left ventricular dysfunction. N Engl J Med. 2011 Apr 28;364(17):1607-16. doi: 10.1056/NEJMoa1100356. Epub 2011 Apr 4.
PubMed 21463150Chareonthaitawee P, Gersh BJ, Araoz PA, Gibbons RJ. Revascularization in severe left ventricular dysfunction: the role of viability testing. J Am Coll Cardiol. 2005 Aug 16;46(4):567-74. doi: 10.1016/j.jacc.2005.03.072.
PubMed 16098417Cleland JG, Calvert M, Freemantle N, Arrow Y, Ball SG, Bonser RS, Chattopadhyay S, Norell MS, Pennell DJ, Senior R. The Heart Failure Revascularisation Trial (HEART). Eur J Heart Fail. 2011 Feb;13(2):227-33. doi: 10.1093/eurjhf/hfq230. Epub 2010 Dec 13.
PubMed 21156659Varnauskas E. Twelve-year follow-up of survival in the randomized European Coronary Surgery Study. N Engl J Med. 1988 Aug 11;319(6):332-7. doi: 10.1056/NEJM198808113190603.
PubMed 3260659Veterans Administration Coronary Artery Bypass Surgery Cooperative Study Group. Eleven-year survival in the Veterans Administration randomized trial of coronary bypass surgery for stable angina. N Engl J Med. 1984 Nov 22;311(21):1333-9. doi: 10.1056/NEJM198411223112102.
PubMed 6333636Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Survival data. Circulation. 1983 Nov;68(5):939-50. doi: 10.1161/01.cir.68.5.939.
PubMed 6137292