An interventional study of Selective invasive angiography based on CT/CCTA imaging. and Procedure/Surgery: Invasive angiography in Severe Aortic Stenosis and Transcatheter Aortic Valve Implantation, sponsored by BC Centre for Improved Cardiovascular Health. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by BC Centre for Improved Cardiovascular Health · Not applicable, Interventional, and Other
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.
Exclusion Criteria:
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.
Procedure: Selective invasive angiography based on CT/CCTA imaging.
Patients will undergo systematic invasive angiography.
Procedure: Procedure/Surgery: Invasive angiography
Number of patients enrolled in the study of all those that are eligible
This is the primary outcome for this pilot study to assess feasibility of a larger trial.
Time frame: 18 months
All-cause mortality
Time frame: 90 days
Myocardial Infarction
According to Valvular Academic Research Consortium-2 (VARC-2) criteria. * Periprocedural MI (≤72h post procedure). * Spontaneous MI.
Time frame: Peri-procedural (≤72h post procedure) and 90 days
Unplanned revascularization
Any unplanned coronary revascularization either with Percutaneous Coronary Intervention( PCI) or Coronary Artery Bypass Graft (CABG) post TAVI procedure.
Time frame: 90 days
Bleeding complication
According to VARC-2 criteria. * TAVI related ≤ 72h post TAVI * Coronary procedure related ≤ 72h post CA or PCI (if staged TAVI-PCI)
Time frame: Peri-procedural (≤72h post procedure) and 90 days
Device success
According to VARC-2 criteria.
Time frame: 90 days
Acute Kidney Injury
According to VARC-2 criteria.
Time frame: 90 days
Stroke
An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as assessed by a clinician and confirmed by at least one cerebral imaging study (CT or MRI). Stroke may be classified as ischaemic or haemorrhagic
Time frame: 90 days
Plan to share: No
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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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BC Centre for Improved Cardiovascular Health