IMPACTavi: NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation

Sponsor

Deutsches Herzzentrum Muenchen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04976062

Collaborator

Infraredx Inc (Other)

100

Enrollment

Location

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Aortic Stenosis, Severe	Diagnostic Test: Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation; the IMPACTavi Trial

Actual Study Start Date :

Nov 10, 2020

Anticipated Primary Completion Date :

May 10, 2024

Anticipated Study Completion Date :

May 10, 2024

Outcome Measures

Primary Outcome Measures

Incidence of major adverse cardiac events as assessed during clinical follow-up and according to current VARC-definitions [24 months]
Major adverse cardiac events (MACE) is defined as the composite of all-cause mortality, myocardial infarction, unplanned coronary revascularization and hospital readmission due to acute coronary syndrome

Secondary Outcome Measures

Freedom from NIRS-IVUS-emergent complications as assessed by post-NIRS-IVUS control angiography [3 months]
NIRS-IVUS-emergent complications are defined as coronary impairment following performance of NIRS-IVUS imaging
Incidence of acute kidney injury as assessed during clinical follow-up and according to RIFLE/AKIN-criteria [3 months]
Incidence of major vascular complications as assessed during clinical follow-up and according to current VARC-defintions [3 months]
Incidence of major- or life-threatening bleedings as assessed during clinical follow-up and according to current VARC-definitions [3 months]
Incidence of any stroke as assessed during clinical follow-up and according to current VARC-definitions [3 months]
Incidence of all-cause mortality as assessed during clinical follow-up [24-months]
Incidence of myocardial infarction as assessed during clinical follow-up according to current VARC-definitions [24 months]
Incidence of unplanned coronary revascularization as assessed during clinical follow-up [24 months]
Incidence of hospital readmission as assessed during clinical follow-up [24 months]
Incidence of any coronary revascularization as assessed during clinical follow-up [24 months]
Incidence of hospital readmission due to angina pectoris or equivalent as assessed during clinical follow-up [24 months]
NYHA class as defined by the New York Heart Association Functional Classification assessed at 24-months clinical follow-up [24 months]
CCS class as defined by the Canadian Cardiovascular Society grading of angina pectoris assessed at 24-months clinical follow-up [24 months]
Delta left-ventricular ejection fraction at 3- and 12-months follow-up compared to baseline [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years and able to give consent
Severe aortic stenosis found eligible for transfemoral TAVI by the multi-disciplinary heart team
Angiographic evidence of coronary artery disease with absence of coronary stents in at least one native coronary artery
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
Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

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