Coronary Artery Disease Clinical Trial
— IMPACTaviOfficial title:
NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation; the IMPACTavi Trial
Verified date | November 2022 |
Source | Deutsches Herzzentrum Muenchen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Deutsches Herzzentrum München | Munich | Bavaria |
Switzerland | Universitätsspital Zürich | Zürich |
Lead Sponsor | Collaborator |
---|---|
Deutsches Herzzentrum Muenchen | Infraredx Inc |
Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Incidence of acute kidney injury according to RIFLE/AKIN-criteria assessed during initial hospital stay, on average 5 days | initial hospital stay | ||
Secondary | Incidence of major vascular complications according to current VARC-defintions, assessed during initial hospital stay, on average 5 days | initial hospital stay | ||
Secondary | Incidence of major- or life-threatening bleedings according to current VARC-definitions, assessed during initial hospital stay, on average 5 days | initial hospital stay | ||
Secondary | Incidence of any stroke according to current VARC-definitions, assessed during initial hospital stay, on average 5 days | initial hospital stay | ||
Secondary | Incidence of all-cause mortality as assessed during clinical follow-up | 24-months | ||
Secondary | Incidence of myocardial infarction as assessed during clinical follow-up according to current VARC-definitions | 24 months | ||
Secondary | Incidence of unplanned coronary revascularization as assessed during clinical follow-up | 24 months | ||
Secondary | Incidence of hospital readmission as assessed during clinical follow-up | 24 months | ||
Secondary | Incidence of any coronary revascularization as assessed during clinical follow-up | 24 months | ||
Secondary | Incidence of hospital readmission due to angina pectoris or equivalent as assessed during clinical follow-up | 24 months | ||
Secondary | NYHA class as defined by the New York Heart Association Functional Classification assessed at 24-months clinical follow-up | 24 months | ||
Secondary | CCS class as defined by the Canadian Cardiovascular Society grading of angina pectoris assessed at 24-months clinical follow-up | 24 months | ||
Secondary | Delta left-ventricular ejection fraction at 3- and 12-months follow-up compared to baseline | 24 months |
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