Coronary Artery DiseaseIMPACTaviNCT04976062
NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation
An observational study of Coronary Artery Disease and Aortic Stenosis, Severe, run by Deutsches Herzzentrum Muenchen at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Aortic Stenosis, Severe
- What is being tested?
- Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Nov 2020to 31 Dec 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe aortic stenosis referred for TAVI with concomitant coronary artery disease
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum München
Munich, Bavaria, 80636
Michael Joner, Prof. Dr. med., +49 89 12180, joner@dhm.mhn.de
Tobias Lenz, Dr. med., +49 89 12180, lenzt@dhm.mhn.de
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Zürich
Zurich, 8091
Barbara Stähli, Prof. Dr. med., +41 44 255 11 11, barbara.staehli@usz.ch
Rahel Kesterke, Dr. sc. nat., +41 43 253 10 37, rahel.kesterke@usz.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Aortic Stenosis, Severe
- Being tested
- Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)
- Keywords
- Transcatheter aortic valve implantation, Near-infrared spectroscopy, Intravascular imaging
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
NIRS-IVUS-emergent complications are defined as coronary impairment following performance of NIRS-IVUS imaging
Measured: initial hospital stay
Incidence of acute kidney injury according to RIFLE/AKIN-criteria assessed during initial hospital stay, on average 5 days
Measured: initial hospital stay
Incidence of major vascular complications according to current VARC-defintions, assessed during initial hospital stay, on average 5 days
Measured: initial hospital stay
Incidence of major- or life-threatening bleedings according to current VARC-definitions, assessed during initial hospital stay, on average 5 days
Measured: initial hospital stay
Incidence of any stroke according to current VARC-definitions, assessed during initial hospital stay, on average 5 days
Measured: initial hospital stay
Incidence of all-cause mortality as assessed during clinical follow-up
Measured: 24-months
Incidence of myocardial infarction as assessed during clinical follow-up according to current VARC-definitions
Measured: 24 months
Incidence of unplanned coronary revascularization as assessed during clinical follow-up
Measured: 24 months
Incidence of hospital readmission as assessed during clinical follow-up
Measured: 24 months
Incidence of any coronary revascularization as assessed during clinical follow-up
Measured: 24 months
Incidence of hospital readmission due to angina pectoris or equivalent as assessed during clinical follow-up
Measured: 24 months
NYHA class as defined by the New York Heart Association Functional Classification assessed at 24-months clinical follow-up
Measured: 24 months
CCS class as defined by the Canadian Cardiovascular Society grading of angina pectoris assessed at 24-months clinical follow-up
Measured: 24 months
Delta left-ventricular ejection fraction at 3- and 12-months follow-up compared to baseline
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start10 Nov 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Infraredx Inc
- Responsible party
- Sponsor
- Investigators
- Michael Joner, MD, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976062
- Sponsor's protocol ID
- GE IDE No. T00120
- Acronym
- IMPACTavi
- Status last verified
- Nov 2022
- First submitted
- 4 Jul 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation; the IMPACTavi Trial
- ClinicalTrials.gov ID
- NCT04976062
- Acronym / sponsor ID
- IMPACTavi / GE IDE No. T00120
- Conditions
- Coronary Artery Disease, Aortic Stenosis, Severe
- Keywords
- Transcatheter aortic valve implantation, Near-infrared spectroscopy, Intravascular imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Infraredx Inc
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe aortic stenosis referred for TAVI with concomitant coronary artery disease
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)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. | Diagnostic test | – |
Primary outcome
Incidence of major adverse cardiac events as assessed during clinical follow-up and according to current VARC-definitions
Time frame: 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
14 secondary outcomes
Freedom from NIRS-IVUS-emergent complications as assessed by post-NIRS-IVUS control angiography during initial hospital stay, on average 5 days
Time frame: initial hospital stay
Incidence of acute kidney injury according to RIFLE/AKIN-criteria assessed during initial hospital stay, on average 5 days
Time frame: initial hospital stay
Incidence of major vascular complications according to current VARC-defintions, assessed during initial hospital stay, on average 5 days
Time frame: initial hospital stay
Incidence of major- or life-threatening bleedings according to current VARC-definitions, assessed during initial hospital stay, on average 5 days
Time frame: initial hospital stay
Incidence of any stroke according to current VARC-definitions, assessed during initial hospital stay, on average 5 days
Time frame: initial hospital stay
Incidence of all-cause mortality as assessed during clinical follow-up
Time frame: 24-months
Incidence of myocardial infarction as assessed during clinical follow-up according to current VARC-definitions
Time frame: 24 months
Incidence of unplanned coronary revascularization as assessed during clinical follow-up
Time frame: 24 months
Incidence of hospital readmission as assessed during clinical follow-up
Time frame: 24 months
Incidence of any coronary revascularization as assessed during clinical follow-up
Time frame: 24 months
Incidence of hospital readmission due to angina pectoris or equivalent as assessed during clinical follow-up
Time frame: 24 months
NYHA class as defined by the New York Heart Association Functional Classification assessed at 24-months clinical follow-up
Time frame: 24 months
CCS class as defined by the Canadian Cardiovascular Society grading of angina pectoris assessed at 24-months clinical follow-up
Time frame: 24 months
Delta left-ventricular ejection fraction at 3- and 12-months follow-up compared to baseline
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Joner, MD principal investigator
Deutsches Herzzentrum München
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Aortic Stenosis, Severe, run by Deutsches Herzzentrum Muenchen at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiac events as assessed during clinical follow-up and according to current VARC-definitions (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.