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Selective invasive angiography based on CT/CCTA imaging for Aortic Stenosis (CT-CA Trial)

N/A
Waitlist Available
Led By Jonathon Leipsic, MD
Research Sponsored by BC Centre for Improved Cardiovascular Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

CT-CA Trial Summary

This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI) procedure. The study will also estimate the rate of composite coronary adverse events (myocardial infarction, post procedural coronary revascularization and cardiovascular mortality) between the two arms at 90 days follow-up. The primary endpoint will be the feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1 site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular complications events. This information will be used to inform the design of the definitive efficacy trial.

Eligible Conditions
  • Aortic Stenosis
  • Transcatheter Aortic Valve Replacement (TAVR)

CT-CA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients enrolled in the study of all those that are eligible
Secondary outcome measures
Acute Kidney Injury
All-cause mortality
Bleeding complication
+4 more

CT-CA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Selective invasive angiography based on CT/CCTA imagingExperimental Treatment1 Intervention
Patients will undergo selective invasive angiography based on CT/CCTA imaging. Decision to procede with additional invasive CA will be based on adequacy of CT/CCTA evaluation and likelihood of significant coronary artery disease.
Group II: Invasive Cardiac AngiographyActive Control1 Intervention
Patients will undergo systematic invasive angiography.

Find a Location

Who is running the clinical trial?

BC Centre for Improved Cardiovascular HealthLead Sponsor
3 Previous Clinical Trials
24,726 Total Patients Enrolled
Edwards LifesciencesIndustry Sponsor
180 Previous Clinical Trials
61,374 Total Patients Enrolled
Jonathon Leipsic, MDPrincipal InvestigatorSt. Paul's Hospital
1 Previous Clinical Trials
6,384 Total Patients Enrolled

Frequently Asked Questions

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~24 spots leftby Apr 2025