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

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ClinicalTrials.gov Identifier: NCT04976062
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : July 26, 2021
Sponsor:
Collaborator:
Infraredx Inc
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Tracking Information
First Submitted Date July 4, 2021
First Posted Date July 26, 2021
Last Update Posted Date July 26, 2021
Actual Study Start Date November 10, 2020
Estimated Primary Completion Date May 10, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2021)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 14, 2021)
  • Freedom from NIRS-IVUS-emergent complications as assessed by post-NIRS-IVUS control angiography [ Time Frame: 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 [ Time Frame: 3 months ]
  • Incidence of major vascular complications as assessed during clinical follow-up and according to current VARC-defintions [ Time Frame: 3 months ]
  • Incidence of major- or life-threatening bleedings as assessed during clinical follow-up and according to current VARC-definitions [ Time Frame: 3 months ]
  • Incidence of any stroke as assessed during clinical follow-up and according to current VARC-definitions [ Time Frame: 3 months ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 24 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with severe aortic stenosis referred for TAVI with concomitant coronary artery disease
Condition
  • Coronary Artery Disease
  • Aortic Stenosis, Severe
Intervention Diagnostic Test: 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 14, 2021)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 10, 2024
Estimated Primary Completion Date May 10, 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04976062
Other Study ID Numbers GE IDE No. T00120
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Deutsches Herzzentrum Muenchen
Study Sponsor Deutsches Herzzentrum Muenchen
Collaborators Infraredx Inc
Investigators
Principal Investigator: Michael Joner, MD Deutsches Herzzentrum München
PRS Account Deutsches Herzzentrum Muenchen
Verification Date July 2021