Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study
NCT04929496
Angina Pectoris, Angina, Stable
Québec, Quebec, Canada
View Trial DetailsNCT Number: NCT06436092
JDEPTH-LM Registry is a prospective, observational, multi-center study designed for the efficacy and safety of Double-effect kissing balloon technique (W-KBT) in left main (LM) bifurcation percutaneous coronary intervention (PCI) using Perfusion balloon (PB) and Drug coated balloon (DCB) in patients with left main coronary artery disease (LMD) with left circumflex artery (LCx) ostium stenosis.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ichinomiya Municipal Hospital, Ichinomiya, Aichi-ken, Japan
JDEPTH-LM Registry is a prospective observational multi-center study. The investigators will enroll and treat patients in the registry who meet the selection criteria under usual care and for whom PCI with W-KBT following on crossover stenting for LMT-LAD direction, proximal optimization technique (POT), and conventional kissing balloon technique (C-KBT) is the optimal treatment. The operators shall obtain oral or written consent from patients who meet the criteria before performing PCI, indicating the intention to perform PCI with W-KBT, and shall keep records. The investigators will continuously register cases attempting PCI with W-KBT according to the protocol and evaluate its efficacy and safety using data from this multi-center registry.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During PCI procedure
indicating the proportion of cases meeting the following three conditions:
Time frame: Within 12 months of PCI procedure
consisting of all-cause mortality, nonfatal myocardial infarction (MI), and ischemia-driven unplanned revascularization for left main disease
Time frame: During PCI procedure
confirming the time from the initiation of W-KBT to any ST elevation/depression in the electrocardiogram (ECG) to evaluate the safety of the procedure
Time frame: During PCI procedure
confirming the duration for which the inflation of the DCB can be sustained during W-KBT, as the recommendation time of DCB inflation is at least 30 seconds
Time frame: During PCI procedure
confirming the extent of blood pressure and heart rate changes resulting from maintaining W-KBT for 30 seconds or longer in the left main coronary trunk (LMT)
Time frame: During PCI procedure
confirming that hemodynamics is not disturbed by W-KBT for LMD
Time frame: Within 12 months of PCI
confirming the frequency of occurrences for each component of MACE
Time frame: During PCI procedure
Fractional flow reserve (FFR) values will be measured before and after each KBT, using either a conventional balloon or PB
Time frame: During PCI procedure
confirming that ECG changes can easily recover even after W-KBT for LMD
Time frame: Within 12 months of PCI
Time frame: During PCI procedure
Time frame: Within 12 months of PCI
Time frame: During PCI procedure
Time frame: During PCI procedure & Within 12 months of PCI
The incidence rate will be calculated using the median LVEF or 40% as the cutoff
Time frame: During PCI procedure & Within 12 months of PCI
comparing efficacy and safety among various groups based on PCI operators' experience
Time frame: During PCI procedure & Within 12 months of PCI
in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)
Time frame: Within 12 months of PCI
Contact information is provided by the study sponsor or research team.
TCROSS Co., Ltd.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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