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

NCT04976062 | Unknown

• 1 other identifier: GE IDE No. T00120
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 2

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.

Conditions

Coronary Artery Disease; Aortic Stenosis, Severe

Keywords

Transcatheter aortic valve implantation; Near-infrared spectroscopy; Intravascular imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Freedom from NIRS-IVUS-emergent complications as assessed by post-NIRS-IVUS control angiography during initial hospital stay, on average 5 days

  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

Interventions

Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS) DIAGNOSTIC_TEST

The NIRS-IVUS technique is an intravascular imaging technique, combining morphological information derived from intravascular ultrasound (IVUS) and molecular information on plaque composition, namely its respective lipid-core burden, using spectral differences between cholesterol and collagen, detected by near-infrared spectroscopy (NIRS). A combined NIRS-IVUS pullback results in a color-coded map indicating the probability of lipid-rich plaque presence in yellow, co-registered to the corresponding IVUS cross-sections.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Infraredx Inc: collaborator

Study Sites (2)

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

RECRUITING

Universitätsspital Zürich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• Michael Joner, MD

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 26, 2021
• Study Start: November 10, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

DE (1); CH (1)