Computed Tomography Angiography Prediction Score for Side Branch Occlusion (CT-PRECISION)
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|ClinicalTrials.gov Identifier: NCT03709836|
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Lesions involving coronary bifurcations account for approximately 20% of all percutaneous coronary interventions (PCI). Revascularization within bifurcation sites remains technically challenging. While the most optimal interventional treatment strategy for bifurcation lesions is still debatable, side branch (SB) occlusion is one of the most serious procedural complications with prevalence rates over 7%.
Numerous mechanisms of the SB occlusion (e.g. plaque or carina shift, coronary artery dissection, thromboembolism, coronary artery spasm, etc) have been postulated. Regardless of the cause, loss of the SB is associated with increased risk of periprocedural mortality and myocardial infarction. Therefore, PCI involving coronary bifurcation mandates consideration of the risk of SB compromise. The CT-PRECISION (Computed Tomography angiography PREdiCtIon score for SIde branch Occlusion in coronary bifurcation interventioN) registry was designed to evaluate the application of coronary computed tomography angiography (coronary CTA) for the prediction of SB occlusion during percutaneous revascularization of bifurcation lesions. The main purpose of this single-center study is to develop a noninvasive CTA-based prediction tool to determine the procedural outcome of PCI in bifurcation lesions.
|Condition or disease|
|Coronary Artery Disease|
Coronary CTA allows for precise and noninvasive evaluation of coronary bifurcation lesions. Pre-procedural planning for coronary revascularization using CTA provides detailed characterization of bifurcation anatomy and morphology including the spatial distribution of coronary plaque. To date there has been no compiled CTA-based prediction model for SB occlusion in coronary bifurcation intervention.
The CT-PRECISION registry is a retrospective observational cohort study of patients undergoing preprocedural coronary CTA before PCI involving coronary bifurcation lesions between January 2010 and July 2018. The study is designed to enroll 400 consecutive patients undergoing elective main vessel stenting with a provisional approach to the SB at a single high-volume PCI center.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Computed Tomography Angiography Prediction Score for Side Branch Occlusion in Coronary Bifurcation Intervention (CT-PRECISION)|
|Actual Study Start Date :||September 25, 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||January 2019|
- SB occlusion [ Time Frame: intraprocedural ]SB occlusion defined as a any decrease in Thrombolysis in Myocardial Infarction (TIMI) flow grade or the absence of flow in the SB after main vessel stenting
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): NCT03709836
|Contact: Maksymilian P. Opolski, MD, PhDemail@example.com|
|Institute of Cardiology||Recruiting|
|Warsaw, Poland, 04-628|
|Contact: Maksymilian P. Opolski, MD, PhD +48501444303 firstname.lastname@example.org|
|Principal Investigator:||Adam D. Staruch, MD||Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland|
|Study Chair:||Maksymilian P. Opolski, MD, PhD||Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland|
|Study Chair:||Adam Witkowski, MD, PhD||Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland|