The IVL Left Main study is a prospective non-randomised pilot study to investigate the mechanical and procedural outcomes and safety of distal left main stenting with coronary lithotripsy in addition to standard techniques in patients with calcific left main disease and a clinical indication for revascularisation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Intravascular lithotripsy (IVL) will be used to modify coronary artery calcification prior to stent implantation in left main coronary disease. Intravascular ultrasound (IVUS) will be used pre and post IVL and post stenting.
Belfast Health & Social Care Trust
Belfast, Northern Ireland, United Kingdom
Golden Jubilee Hospital
Clydebank, Scotland, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Primary effectiveness endpoint 1
Mean MSA (mm2) by segment for segments with obstructive disease and ≥ 270 degrees calcification.
Time frame: Time of procedure
Primary effectiveness endpoint 2
Incidence of residual area stenosis \<50% by segment for segments with obstructive disease and ≥ 270 degrees calcification.
Time frame: Time of procedure
Primary safety endpoint
Incidence of Major Adverse Cardiac Events (MACE) at 30 days MACE consists of cardiac death, myocardial infarction and target vessel revascularisation
Time frame: 30 days
Minimum stent diameter (MSD) (mm) for segments with obstructive disease and ≥ 270 degrees calcification
Time frame: Time of procedure
Stent symmetry ratio for segments with obstructive disease and ≥ 270 degrees calcification
Time frame: Time of procedure
Stent expansion index (%) for segments with obstructive disease and ≥ 270 degrees calcification
Time frame: Time of procedure
MSA (mm2) for all segments.
Time frame: Time of procedure
MSD (mm) for all segments.
Time frame: Time of procedure
Stent symmetry ratio for all segments.
Time frame: Time of procedure
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Royal Brompton & Harefield NHS Foundation Trust
London, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
Stent expansion (%) for all segments.
Time frame: Time of procedure
Device crossing success
ARC-2 criteria
Time frame: Time of procedure
Angiographic success
ARC-2 criteria
Time frame: Time of procedure
Procedural success
ARC-2 criteria
Time frame: Time of procedure
Serious angiographic complications
ARC-2 criteria. Composite of loss of major vessel/side branch, embolisation, disruption of collateral flow, persistent slow-flow or no reflow, major dissection, new regional wall motion abnormality, imaging evidence of loss of viable myocardium.
Time frame: 24-48 hours
MACE at 12 months
Time frame: 12 months
Individual components of MACE at 30 days
Time frame: 30 days
Individual components of MACE at 12 months
Time frame: 12 months
Canadian Cardiovascular Society (CCS) angina status at 30 days
Time frame: 30 days
Canadian Cardiovascular Society (CCS) angina status at 12 months
Time frame: 12 months
Stroke at 30 days
Time frame: 30 days
Stroke at 12 months
Time frame: 12 months
Target lesion failure (TLF) at 30 days
Time frame: 30 days
Target lesion failure (TLF) at 12 months
Time frame: 12 months
Target vessel failure (TVF) at 30 days
Time frame: 30 days
Target vessel failure (TVF) at 12 months
Time frame: 12 months
All-cause mortality
Stratified by i) cardiac death ii) non-cardiac death
Time frame: 12 months
Peri-procedural myocardial infarction
ARC-2 criteria
Time frame: 48 hours
Spontaneous myocardial infarction
ARC-2 criteria
Time frame: 12 months
Ischaemic-driven revascularisation
Time frame: 12 months
All revascularisation
Time frame: 12 months
Angiographic and intracoronary imaging predictors of mechanical and procedural outcomes
Time frame: 12 months
Correlation between CK-MB and/or troponin levels post-PCI and outcomes at 30-days and 12 months
Time frame: 12 months