Evaluation of Long Coronary Artery Stents With Third-generation Dual-source Computed Tomography Angiography

NCT06543641 | Completed

• 1 other identifier: M1016TUTLA
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess third-generation dual-source coronary computed tomography angiography (CCTA) performance in the evaluation of long coronary stents in patients with coronary artery chronic total occlusions. The main questions it aims to answer are:

• Can patency of long coronary artery stents be assessed with third generation CCTA?
• What are the factors affecting the assessability?
• What is the radiation exposure of third generation CCTA?

Conditions

Coronary Artery Disease; Chronic Total Occlusion of Coronary Artery

Keywords

coronary artery disease; drug-eluting stent; percutaneous coronary intervention; coronary computed tomography angiography

Outcome Measures

Primary Outcomes (1)

• Stent patency assesment with third-generation dual-source CCTA

  Assessability of stent patency with third-generation dual-source CCTA in long coronary artery chronic total occlusion stents. CCTA results were divided into three categories: 1) negative (\<50% stent luminal narrowing), 2) ISR (\> 50% stent luminal narrowing) or 3) inconclusive (CCTA was not able to define the degree of stent luminal narrowing). Patients with ISR or inconclusive result were considered as CCTA positive. Confirmation imaging was conducted with ICA, if necessary. Positive predictive value, negative predictive value, sensitivity and specificity were calculated.

  up to 7.3 months (maximum time between CCTA and ICA)

Secondary Outcomes (2)

• To determine significant differences in distribution of patient- and lesion-related characteristics in third-generation dual-source CCTA negative versus positive patient groups.

  through study completion, average of 1 year

• To compare radiation exposure of third-generation dual-source CCTA to ICA, measured as effective dose, in patients receiving both examinations.

  from CCTA to possible ICA, up two 7.3 months

Study Arms (1)

Study population

OTHER

All patients included in the study.

Diagnostic Test: Coronary computed tomography angiography; Diagnostic Test: Invasive coronary angiography

Interventions

Coronary computed tomography angiography DIAGNOSTIC_TEST

All patients received coronary computed tomography angiography.

Also known as: CCTA

Study population

Invasive coronary angiography DIAGNOSTIC_TEST

According to the study criteria some of the patients received confirmation imaging with invasive coronary angiography.

Also known as: ICA

Study population

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Surviving patients with a CTO PCI minimum of four years prior to the study date
• Successful CTO PCI with a drug-eluting stent
• Primary procedure minimum of four years prior to study date
• CTO stent length ≥ 38 mm in right coronary artery (RCA) and left anterior descending (LAD) coronary artery
• CTO stent length ≥ 30 mm in left circumflex coronary artery (LCX). The definition is clinical.
• Age at primary procedure ≤ 75 years
• Communication in English, Finnish or Swedish

You may not qualify if:

• Malignancy with poor prognosis or ongoing diagnostics
• Significantly impaired performance in daily activities
• Significant psychiatric disorder
• Active alcohol or drug abuse
• Memory disorder or other cognitive impairment
• Primary procedure in-stent CTO PCI
• Target vessel revascularisation or CABG after the primary - procedure
• Glomerular filtration rate ≤40 ml/min
• ICA or CCTA less than six months prior to the study date

Sponsors & Collaborators

• Lauri Mansikkaniemi: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00290, Finland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Petri Laine, Ph.D.

  Department of Cardiology, Heart and Lung Center, Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study's cardiac radiologist was blinded for symptomatic data, stent type and stent quantity. The target vessel of implanted coronary artery stents was provided.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 9, 2024
• Study Start: January 16, 2023
• Primary Completion: November 10, 2023
• Study Completion: June 8, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)