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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Aortic Stenosis, Severe
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80636
      • Recruiting
      • Deutsches Herzzentrum München
      • Contact: Michael Joner, Prof. Dr. med.; Phone Number: +49 89 12180; Email: joner@dhm.mhn.de
      • Contact: Tobias Lenz, Dr. med.; Phone Number: +49 89 12180; Email: lenzt@dhm.mhn.de
      • Sub-Investigator: Tobias Lenz, MD
• Switzerland
  • Zürich, Switzerland, 8091
    • Recruiting
    • Universitatsspital Zurich
    • Contact: Barbara Stähli, Prof. Dr. med.; Phone Number: +41 44 255 11 11; Email: barbara.staehli@usz.ch
    • Contact: Rahel Kesterke, Dr. sc. nat.; Phone Number: +41 43 253 10 37; Email: rahel.kesterke@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe aortic stenosis referred for TAVI with concomitant coronary artery disease

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse cardiac events as assessed during clinical follow-up and according to current VARC-definitions	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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from NIRS-IVUS-emergent complications as assessed by post-NIRS-IVUS control angiography during initial hospital stay, on average 5 days	NIRS-IVUS-emergent complications are defined as coronary impairment following performance of NIRS-IVUS imaging	initial hospital stay
Incidence of acute kidney injury according to RIFLE/AKIN-criteria assessed during initial hospital stay, on average 5 days		initial hospital stay
Incidence of major vascular complications according to current VARC-defintions, assessed during initial hospital stay, on average 5 days		initial hospital stay
Incidence of major- or life-threatening bleedings according to current VARC-definitions, assessed during initial hospital stay, on average 5 days		initial hospital stay
Incidence of any stroke according to current VARC-definitions, assessed during initial hospital stay, on average 5 days		initial hospital stay
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

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Collaborators: Infraredx Inc
• Investigators: Principal Investigator: Michael Joner, MD, Deutsches Herzzentrum München

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2020
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (ACTUAL): July 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Transcatheter aortic valve implantation; Near-infrared spectroscopy; Intravascular imaging
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Aortic Valve Stenosis
• Other Study ID Numbers: GE IDE No. T00120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED