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Computed Tomography Angiography Prediction Score for Side Branch Occlusion

NCT ID: NCT03709836

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

363 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-25

Study Completion Date

2019-01-01

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam D. Staruch, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland

Maksymilian P. Opolski, MD, PhD

Role: STUDY_CHAIR

Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland

Adam Witkowski, MD, PhD

Role: STUDY_CHAIR

Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland

Locations

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Institute of Cardiology

Warsaw, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 32385529 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31806391 (View on PubMed)

Other Identifiers

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2.43/III/16

Identifier Type: -

Identifier Source: org_study_id