NCT03709836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 15, 2018

Last Update Submit

October 30, 2020

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseaseCoronary bifurcation lesionCoronary angiographyCoronary computed tomography angiographyPercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • SB occlusion

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiology

Warsaw, 04-628, Poland

Location

Related Publications (2)

  • 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.

    PMID: 32385529DERIVED

  • 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.

    PMID: 31806391DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Adam D. Staruch, MD

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

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 17, 2018

Study Start

September 25, 2018

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations

PL(1)