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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
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland

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.


Condition or disease
Coronary Artery Disease

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
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
Contact: Maksymilian P. Opolski, MD, PhD +48223434272 mopolski@ikard.pl

Locations
Poland
Institute of Cardiology Recruiting
Warsaw, Poland, 04-628
Contact: Maksymilian P. Opolski, MD, PhD    +48501444303    mopolski@ikard.pl   
Sponsors and Collaborators
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

Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT03709836     History of Changes
Other Study ID Numbers: 2.43/III/16
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Coronary artery disease
Coronary bifurcation lesion
Coronary angiography
Coronary computed tomography angiography
Percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases