Clinical trial NCT04976062: NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation
Official title: NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation; the IMPACTavi Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Aortic Stenosis, Severe
Keywords: Transcatheter aortic valve implantation
Near-infrared spectroscopy
Intravascular imaging
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Infraredx Inc
First posted: 2021-07-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe aortic stenosis referred for TAVI with concomitant coronary artery disease

Brief summary: The aim of the IMPACTavi prospective cohort study is to test feasibility and safety of clinically indicated intravascular coronary imaging with NIRS-IVUS in addition to routine coronary angiography in patients scheduled for TAVI, to improve assessment of CAD severity in this challenging group of patients.

Detailed description: Concomitant coronary artery disease (CAD) is frequent in patients referred for transcatheter aortic valve replacement (TAVI) and there is evidence for a subsequent prognostic impairment. Percutaneous coronary intervention (PCI) is believed to improve prognosis in selected cases, which is why current guidelines recommend PCI to be considered in case of coronary artery diameter stenosis \> 70% in proximal segments. Beyond those cases, selection is hampered by inherent shortcoming of the assessment of CAD severity by angiography alone as well as clinical and complex hemodynamic interactions between both pathologies. In patients with CAD alone, the FDA-cleared near-infrared spectroscopy and intravascular imaging (NIRS-IVUS) dual imaging catheter (Indfraredx, Inc., Bedford, USA) has proven the ability to reliably measure lipid plaque burden as well as to identify patients and plaques at increased risk for future adverse cardiovascular events. NIRS-IVUS imaging offers the unique possibility to improve angiographic CAD severity assessment in patients referred for TAVI, avoiding the influence of hemodynamic interactions and pathophysiological overlap between CAD and severe AS.

The IMPACTavi trial is designed as a prospective, non-randomized cohort study to investigate whether NIRS-IVUS-derived lesion characteristics will allow identification of patients likely to suffer adverse clinical events during clinical follow-up after TAVI. Patients with severe aortic stenosis will be qualified for enrollment if routine coronary angiography during diagnostic workup before TAVI shows evidence of coronary artery disease with at least one native vessel without prior stent implantation and at least one lesion requiring NIRS-IVUS imaging for clinical indications, and if at 30mm of total NIRS-IVUS pullback length in sufficient quality for offline analysis have been obtained. Clinical indication, technique and timing of PCI and TAVI will be at the discretion of the interdisciplinary heart-team. The primary and secondary endpoints will be assessed during clinical follow-up out to 24 months. Findings from NIRS-IVUS imaging will be analyzed on a patient- and lesion-level, in order to evaluate correlations of high- vs. low-risk lesion characteristics to the incidence of patient- and lesion-level MACE.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years and able to give consent
2. Severe aortic stenosis found eligible for transfemoral TAVI by the multi-disciplinary heart team
3. Angiographic evidence of coronary artery disease with absence of coronary stents in at least one native coronary artery
4. At least 30 mm of total NIRS-IVUS pullback length in sufficient quality for offline analysis of at least one native coronary artery with absence of coronary stents, containing at least one lesion requiring NIRS-IVUS imaging for clinical indications
5. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
6. In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

1. Age \< 18years
2. Any clinical contraindications to perform NIRS-IVUS
3. ST-elevation myocardial infarction or cardiogenic shock within 48h prior to enrollment
4. Decompensated aortic valve stenosis requiring emergency TAVI
5. History of coronary artery bypass graft (CABG)
6. Severe renal failure with estimated glomerular filtration rate \<20 ml/min
7. Malignancies or other comorbid conditions (resulting in a life expectancy \<12 months)
8. Inability to fully cooperate with the study protocol
9. Known allergy towards P2Y12 receptor antagonists
10. Pregnancy

Primary outcomes:
measure: Incidence of major adverse cardiac events as assessed during clinical follow-up and according to current VARC-definitions
timeFrame: 24 months
Secondary outcomes:
measure: Freedom from NIRS-IVUS-emergent complications as assessed by post-NIRS-IVUS control angiography during initial hospital stay, on average 5 days
timeFrame: initial hospital stay
measure: Incidence of acute kidney injury according to RIFLE/AKIN-criteria assessed during initial hospital stay, on average 5 days
timeFrame: initial hospital stay
measure: Incidence of major vascular complications according to current VARC-defintions, assessed during initial hospital stay, on average 5 days
timeFrame: initial hospital stay
measure: Incidence of major- or life-threatening bleedings according to current VARC-definitions, assessed during initial hospital stay, on average 5 days
timeFrame: initial hospital stay
measure: Incidence of any stroke according to current VARC-definitions, assessed during initial hospital stay, on average 5 days
timeFrame: initial hospital stay
measure: Incidence of all-cause mortality as assessed during clinical follow-up
timeFrame: 24-months
measure: Incidence of myocardial infarction as assessed during clinical follow-up according to current VARC-definitions
timeFrame: 24 months
measure: Incidence of unplanned coronary revascularization as assessed during clinical follow-up
timeFrame: 24 months
measure: Incidence of hospital readmission as assessed during clinical follow-up
timeFrame: 24 months
measure: Incidence of any coronary revascularization as assessed during clinical follow-up
timeFrame: 24 months
measure: Incidence of hospital readmission due to angina pectoris or equivalent as assessed during clinical follow-up
timeFrame: 24 months
measure: NYHA class as defined by the New York Heart Association Functional Classification assessed at 24-months clinical follow-up
timeFrame: 24 months
measure: CCS class as defined by the Canadian Cardiovascular Society grading of angina pectoris assessed at 24-months clinical follow-up
timeFrame: 24 months
measure: Delta left-ventricular ejection fraction at 3- and 12-months follow-up compared to baseline
timeFrame: 24 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
state: Bavaria
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Deutsches Herzzentrum München
name: Michael Joner, MD
role: PRINCIPAL_INVESTIGATOR
References: