NCT03641898|Unknown
Intravascular Ultrasound-derived Assessment of Hemodynamically Negative Lesions in NSTEACS Patients
IMPACT-NSTEACS
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IMPACT-NSTEACS
Sponsor study identifier
observational
350
1 country
1
Study Start
October 20, 2018
Actual (reported)Primary Completion
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is an observational and prospective cohort study to examine whether the addition of IVUS plaque morphological evaluation to FFR haemodynamic assessment of non-culprit lesions in NSTEACS patients will better predict MACEs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 18, 2018
Actual (reported)August 22, 2018
Actual (reported)October 20, 2018
Actual (reported)October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The incidence and predictors of MACEs related to FNLs
Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
3 years
The incidence of MACEs related to PCI-treated lesions
3 years
The incidence and predictors of MACEs related to FNLs
5 years
The incidence of MACEs related to PCI-treated lesions
5 years
After FFR-guided PCI, the morphometric characteristics of FNLs (FFR\>0.8) are assessment by intravascular ultrasound.
After the angiographic screening for lesions with 40%-90% diameter stenosis, FFR will be performed according to standard protocol using the s5 console and PrimeWire Prestige PLUS coronary pressure wire (Volcano Corporation, San Diego, California). FFR is calculated as the ratio of mean distal intracoronary pressure measured by the pressure wire, and the mean arterial pressure measured through the coronary guiding catheter. An FFR ≤0.8 or \>90% diameter stenosis should result in a treatment decision for revascularization by PCI and lesions with FFR \>0.80 are defined as FNLs and should result in deferral of PCI.
For study enrollment, we screen patients with NSTEACS combination of unstable angina and non-ST-segment elevation myocardial infarction according to current guidelines. Once all clinical inclusion criteria and no clinical exclusion criteria are met, patients must sign the informed consent and undergo invasive coronary angiography (ICA). During ICA patients will be further analyzed for eligibility using angiographic inclusion and exclusion criteria. Patients will be enrolled into the study once the IVUS measurement is delivered after successful FFR-guided PCI.
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300000, China
Ying Zhang, MD
Tianjin Chest Hospital
First Submitted
August 18, 2018
First Posted
August 22, 2018
Study Start
October 20, 2018
Actual (reported)Primary Completion
October 2023
Estimated (date passed)A Prospective Study on IVUS and DSA Guidance in the Treatment of Budd-Chiari Syndrome
After the successful FFR-guided PCI, IVUS will be performed in all FNLs with the ultrasound Imaging Catheter Atlantis™ SR Pro (40 MHz, mechanical-type transducer, 3.2 F, Boston Scientific Corporation, Natick, MA, USA). Quantitative analyses of grayscale IVUS include contouring external elastic membrane (EEM) and luminal borders and the measurement of EEM cross-sectional area (CSA), luminal CSA, plaque and media CSA, plaque burdenand remodeling index. Virtual assessment of plaque is performed with iMap software (QIvus 2.0; Medis Medical Imaging Systems, Leiden, The Netherlands). Plaque components are categorized as dense calcium, necrotic core, fibrofatty, and fibrous tissue and reported as absolute area and proportion of total plaque area.
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Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 10, 2019
Record last verified: 2019-07
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