Computed Tomography Angiography Prediction Score for Side Branch Occlusion (CT-PRECISION)

October 30, 2020 updated by: Institute of Cardiology, Warsaw, Poland

Computed Tomography Angiography Prediction Score for Side Branch Occlusion in Coronary Bifurcation Intervention (CT-PRECISION)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

363

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 04-628
        • Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
intraprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cardiology, Warsaw, Poland

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2018

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 30, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.43/III/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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