Clinical trial NCT03709836: Computed Tomography Angiography Prediction Score for Side Branch Occlusion
Official title: Computed Tomography Angiography Prediction Score for Side Branch Occlusion in Coronary Bifurcation Intervention (CT-PRECISION)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Coronary bifurcation lesion
Coronary angiography
Coronary computed tomography angiography
Percutaneous coronary intervention
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients undergoing preprocedural coronary CTA before attempted PCI involving coronary bifurcation with a significant SB. All consecutive patients meeting all inclusion criteria and no exclusion criteria will be included within the CT-PRECISION registry.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients referred for attempted PCI of a bifurcation lesion with a significant SB as part of their standard of care
* Initial stenting of the main branch with a provisional approach to the SB
* Performance of dual-source coronary CTA within 30 days before attempted PCI

Exclusion Criteria:

* Age \<18 years

Primary outcomes:
measure: SB occlusion
timeFrame: intraprocedural
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland
name: Adam D. Staruch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland
name: Maksymilian P. Opolski, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland
name: Adam Witkowski, MD, PhD
role: STUDY_CHAIR
References:
citation: Grodecki K, Cadet S, Staruch AD, Michalowska AM, Kepka C, Wolny R, Pregowski J, Kruk M, Debski M, Debski A, Michalowska I, Slomka PJ, Witkowski A, Dey D, Opolski MP. Noncalcified plaque burden quantified from coronary computed tomography angiography improves prediction of side branch occlusion after main vessel stenting in bifurcation lesions: results from the CT-PRECISION registry. Clin Res Cardiol. 2021 Jan;110(1):114-123. doi: 10.1007/s00392-020-01658-1. Epub 2020 May 8.
citation: Opolski MP, Grodecki K, Staruch AD, Michalowska AM, Kepka C, Wolny R, Knaapen P, Schumacher SP, Pregowski J, Kruk M, Debski M, Debski A, Michalowska I, Witkowski A. Accuracy of RESOLVE score derived from coronary computed tomography versus visual angiography to predict side branch occlusion in percutaneous bifurcation intervention. J Cardiovasc Comput Tomogr. 2020 May-Jun;14(3):258-265. doi: 10.1016/j.jcct.2019.11.007. Epub 2019 Nov 21.