P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI (P2BiTO)
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|ClinicalTrials.gov Identifier: NCT01967615|
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : October 30, 2017
|Condition or disease|
All patients aged 18-80 who underwent PCI of a CTO or bifurcating lesion (all Medina types, side branch ≥2 mm) with "biologically active stents" (DES or BVS) between January 2012 and december 2014 at participating centers will be deemed eligible to enter the registry.
In-hospital outcomes will be recorded; all patients discharged alive will be followed up with a telephone interview (minimum follow-up 6 months).
The primary end-point will be the occurrence of a cluster of major adverse cardiovascular events at 1 year:
- Death from any cause.
- Myocardial infarction.
- Stent thrombosis, defined as definite, probable or possible following the Academic Research Consortium.
Sample size 3150 patients.
|Study Type :||Observational|
|Actual Enrollment :||4500 participants|
|Official Title:||P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI With Biologically Active Stents (P2BiTO) Registry|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||April 2017|
- Death, Myocardial infarction, Stent Thrombosis [ Time Frame: 30 months ]
- Death from any cause.
- Myocardial infarction, defined as an elevation of the creatine kinase MB fraction or cardiac troponins by a factor of 3 or more, or the development of new Q waves in 2 or more contiguous leads at surface ECG7. Levels of total creatine kinase and the creatine kinase MB fraction will be measured in all patients between 12 and 24 hours after PCI.
- Stent thrombosis, defined as definite, probable or possible3 following the Academic Research Consortium
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967615
|Principal Investigator:||Marco Zimarino, MD||G. d'Annunzio University|