Condition: Coronary Artery Disease · DCB · Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS
This is an investigator-driven prospective, multicentric, international, randomized clinical study, in an open-label randomized fashion, where patients with bifurcation coronary artery disease (Medina: 111,101,011,001) in vessels with diameter \>2.0 (visual estimation) and with a clinical indication to PCI, will be enrolled. After successful predilatation (with any tool deemed useful), patients will be randomized 1:1:1 to SCB, PCB or standard treatment with DES for bifurcation native vessel disease. All patients with a clinical indication for PCI, both stable coronary artery disease and acute coronary syndrome, will be enrolled. Before participating all the candidates will be clearly informed about the study, including the possible risks and benefits, and will be asked to provide a written informed consent. Subjects will be instructed that may not meet the general criteria for inclusion or the angiographic criteria, or that may have at least one exclusion criteria, and then be excluded from the study (screening failure), even after informed consent is obtained. Consecutive patients who meet at least one of the inclusion criteria and none of the exclusion criteria, will participate to the study. After randomization, the procedure will consist in standard coronary angioplasty following international guidelines/consensus documents and as per local practice. If the patient has been randomized to SCB or PCB, it is mandatory to adequately prepare the lesion.
This description comes directly from the study's public registry record.
Bernardo Cortese · 504827636 · bcortese@gmail.com
Wojciech Wańha · 504827636 · wojciech.wanha@gmail.com
Always discuss trial participation with your own doctor first.
| Fondazione Ricerca e Innovazione Cardiovascolare | Milan, Italy | Not Yet Recruiting |
| First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland | Gdansk, Poland | Not Yet Recruiting |
| Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland | Katowice, Poland | Not Yet Recruiting |
| Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland | Krakow, Poland | Not Yet Recruiting |
| Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland | Krakow, Poland | Not Yet Recruiting |
| Department of Cardiology, Copper Health Centre (MCZ) | Lubin, Poland | Not Yet Recruiting |
| Clinical Department of Interventional Cardiology, Medical University of Lublin | Lublin, Poland | Not Yet Recruiting |
| Department of Cardiology, Poznan University of Medical Sciences | Poznan, Poland | Not Yet Recruiting |
| Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow | Rzeszów, Poland | Not Yet Recruiting |
| Department of Cardiology and Internal Diseases, Military Institute of Medicine | Warsaw, Poland | Not Yet Recruiting |
| Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration | Warsaw, Poland | Not Yet Recruiting |
| Department of Cardiology | Wałbrzych, Poland | Not Yet Recruiting |
+ 5 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06551662